First-time Usage of SGLT2 Inhibitors in Patients with Type 2 Diabetes Who Are Fasting Ramadan: Efficacy and Safety

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Abstract Introduction: Ramadan fasting claims a necessary role in management of diabetes. Many people with type 2 diabetes insist on fasting during the holy month of Ramadan, which represents a challenge to their physicians to provide balance between preventing hypoglycemia or diabetic ketoacidosis and good control of hyperglycemia with its short- and long-term complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a glucose-lowering therapy for type 2 diabetes which are generally well tolerated but may carry the risk of dehydration and hypoglycemia particularly during the long fasting hours. The study aimed to assess the efficacy and safety of the use of SGLT2i for the first-time during Ramadan fasting. Methods: This prospective cohort study was carried out on 61 Egyptian Muslim patients, aged ≥ 18 years old, both sexes, with type 2 diabetes mellitus (T2DM), prepared to fast during Ramadan and treated with SGLT2i for the first time as a supplementary to metformin or another oral hypoglycemic drug. The dose of SGLT2i started after Iftar time. During and Six weeks after Ramadan, evaluations were conducted. Results: Glycated hemoglobin (HbA1c), blood pressure (systolic and diastolic), and creatinine were significantly lower after Ramadan than at the beginning of Ramadan. The estimated glomerular filtration rate (eGFR) was significantly higher after Ramadan than at the beginning of Ramadan. Hypoglycemia, dehydration, and diabetic ketoacidosis (DKA) did not occur in any patient. There was a significant negative correlation between age and HbA1c (r=-0.267, P = 0.037) and eGFR (r =-0.684, P < 0.001) after Ramadan while there was no correlation between the duration of DM and HbA1c before and after Ramadan. HbA1c was significantly lower after Ramadan than during Ramadan in patients with ischemic heart disease (IHD), hypertension (HTN), peripheral neuropathy (PN), and chronic kidney disease (CKD) (P < 0.05). Conclusions: SGLT2i is effective and safe during Ramadan fasting with a significant reduction in HBA1c, blood pressure, and creatinine and a significant elevation of eGFR. Trial registration Clinical Trials giv ID: NCT06370247
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Many people with type 2 diabetes insist on fasting during the holy month of Ramadan, which represents a challenge to their physicians to provide balance between preventing hypoglycemia or diabetic ketoacidosis and good control of hyperglycemia with its short- and long-term complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a glucose-lowering therapy for type 2 diabetes which are generally well tolerated but may carry the risk of dehydration and hypoglycemia particularly during the long fasting hours. The study aimed to assess the efficacy and safety of the use of SGLT2i for the first-time during Ramadan fasting. Methods : This prospective cohort study was carried out on 61 Egyptian Muslim patients, aged ≥ 18 years old, both sexes, with type 2 diabetes mellitus (T2DM), prepared to fast during Ramadan and treated with SGLT2i for the first time as a supplementary to metformin or another oral hypoglycemic drug. The dose of SGLT2i started after Iftar time. During and Six weeks after Ramadan, evaluations were conducted. Results : Glycated hemoglobin (HbA1c), blood pressure (systolic and diastolic), and creatinine were significantly lower after Ramadan than at the beginning of Ramadan. The estimated glomerular filtration rate (eGFR) was significantly higher after Ramadan than at the beginning of Ramadan. Hypoglycemia, dehydration, and diabetic ketoacidosis (DKA) did not occur in any patient. There was a significant negative correlation between age and HbA1c (r=-0.267, P = 0.037) and eGFR (r =-0.684, P < 0.001) after Ramadan while there was no correlation between the duration of DM and HbA1c before and after Ramadan. HbA1c was significantly lower after Ramadan than during Ramadan in patients with ischemic heart disease (IHD), hypertension (HTN), peripheral neuropathy (PN), and chronic kidney disease (CKD) (P < 0.05). Conclusions : SGLT2i is effective and safe during Ramadan fasting with a significant reduction in HBA1c, blood pressure, and creatinine and a significant elevation of eGFR. Trial registration Clinical Trials giv ID: NCT06370247 Health sciences/Medical research Health sciences/Endocrinology Efficacy Empagliflozin Dapagliflozin Ramadan Fasting Safety SGLT2 inhibitors Type 2 Diabetes Mellitus Introduction: Muslims worldwide observe a continuous fast from dawn to dusk in the holy month of Ramadan. Ramadan fasting must necessitate substantial alterations in the intake and frequency of meals. All Muslims who fast the holy month of Ramadan have metabolic changes as a result of these alterations [ 1 ] .Many Muslim patients with acute or chronic medical conditions prefer fasting. Religiosity, personal beliefs, and spirituality are crucial factors of the social determinants that impact health-related behaviors and treatment adherence of patients [ 2 , 3 ] . Nevertheless, Fasting is a deeply respected religious practice observed throughout the holy month of Ramadan, and devout Muslim individuals persist in fasting even when their healthcare doctors advise against it. In 2019, globally, approximately, 460 million people were living with diabetes and approximately, 148 million Muslim people were living with diabetes and this number is increasing [ 4 ] . It has been estimated that worldwide 116 million muslim patients with diabetes fast, fasting can significantly affect blood glucose levels and overall metabolism. Patients with type 2 diabetes mellitus (T2DM) need to carefully manage their condition during fasting to avoid acute complications like hypoglycemia or hyperglycemia [ 5 ] . Before Ramadan, several clinical studies, including those using insulin, glucagon-like peptide-1 agonists, sulphonylureas, and dipeptidyl peptidase inhibitors, evaluated the safety of pharmacological diabetic therapies [ 6 – 9 ] . Sodium-glucose cotransporter 2 inhibitors (SGLT2i) represent the most current class development class of oral anti-diabetic drugs having cardiovascular and renal advantages. SGLT2i inhibits the proximal tubule of the kidney's glucose absorption, reducing blood sugar levels. At now, the predominant use of SGLT2i is as anti-diabetic drugs; nevertheless, their benefits extend well beyond mere glycemic regulation [ 10 ] . The study aimed to assess the efficacy and safety of the use of SGLT2i for the first time during Ramadan fasting. So, we can give this drug without delay in Ramadan. Methods: This prospective, cohort study was conducted on 61 Egyptian Muslim patients with T2DM, 18 years or older, both sexes, intending to fast during Ramadan and treated with SGLT2 inhibitors (empagliflozin, or dapagliflozin) as an add-on to metformin or another oral hypoglycemic agent. The research was conducted during Ramadan 2023 after the ethical approval of the Sohag University Hospital ethical committee in Egypt (approval code: Soh-Med-23-4-07PD). Informed written consent was obtained from the patient. The study was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments. The indications of adding SGLT2 inhibitors were; first to more control of blood sugar and second for cardio-renal benefits especially in patients with ischemia or renal affection. Exclusion criteria were chronic liver disease (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase blood levels over twice the normal value upper limit), chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) of below 25 ml/min/1.73 m 2 ], renal dialysis and ketoacidosis during the previous six months, prior diagnosis of cancer within the previous three years, strokes (including transient ischemic attack) and diabetic foot infection, non-traumatic even minor amputation, or gangrene. Also, pregnant, or lactating women and prior occurrence of recurrent urinary tract infections as well as individuals who ceased taking SGLT2i throughout the holy month of Ramadan or fasted for less than 15 days were all excluded. All patients were subjected to full history taken [duration of DM, current medication and other comorbid diseases like hypertension (HTN), ischemic heart disease (IHD), chronic kidney disease (CKD), peripheral neuropathy (PN), dyslipidemia, atherosclerotic cardiovascular diseases, the time of hypoglycemia, the number of symptomatic and recorded episodes of hypoglycemia, the number of days fasting, any hospitalizations required to treat hypoglycemia and hyperglycemia, acute dehydration, or diabetic ketoacidosis (DKA), and any complaints of excessive and unusual thirst)] and clinical assessment [weight, body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)]. We assessed HbA1c, creatinine, eGFR, urine analysis, and serum electrolytes (Na and K) during and after Ramadan assessments were obtained after six weeks. Sulfonylureas (SU) or other oral hypoglycemic medications were modified in observance of Ramadan, and SGLT2i dosing began after Iftar time. Diabetes education related to Ramadan was provided to participants by standard protocols. Awareness and identification of warning indicators of hypoglycemia were assessed and reinforced during Ramadan evaluation. The dosage of SGLT2i (empagliflozin or dapagliflozin) and oral anti-diabetic medicines were provided. Statistical Analysis SPSS V24 (IBM Inc., Chicago, IL, USA) was used for statistical analysis. The mean and standard deviation (SD) were used to represent quantitative variables which were compared by the paired Student t-test. The frequency and percentage were used to represent qualitative variables. The Pearson correlation was used to do the correlation between various variables. A two-tailed P value < 0.05 was considered statistically significant. Results: The mean value (± SD) of age was 50.5 (± 11.21) years. There were 25 (40.98%) male patients. The mean value (± SD) of the duration of DM was 5.8 (± 4.9) years. Hypertension was present in 24 (39.34%) patients. Ischemic heart disease was present in 10 (16.39%) patients. CKD was present in 24 (39.34%) patients. PN was present in 24 (39.34%) patients. 33 (54.1%) patients were receiving dapagliflozin and 36 (59.02%) patients were receiving empagliflozin. Table 1 Table 1 Demographic data, medical history, and SGLT2i of the studied patients Nin = 61) Age (years) 50.5 ± 11.21 Sex Male 25 (40.98%) Female 36 (59.02%) Duration of DM (years) 5.8 ± 4.9 Medical history Hypertension 24 (39.34%) IHD 10 (16.39%) CKD 24 (39.34%) PN 24 (39.34%) Type of SGLT2i Dapagliflozin 33 (54.1%) Empagliflozin 28 (45.9%) Data are presented as mean ± SD or frequency (%). DM: Diabetes mellitus, IHD: Ischemic heart disease. CKD: Chronic kidney disease. PN: Parental nutrition. SGLT2i: Sodium-glucose cotransporter-2. Weight and BMI were insignificantly different between during Ramadan and after Ramadan. Systolic and diastolic blood pressures were significantly lower after Ramadan than during Ramadan (P < 0.001). Table 2 Table 2 Weight, BMI, and blood pressure of the studied patients During Ramadan (n = 61) After Ramadan (n = 61) P value Weight (Kg) 85 ± 15.49 84.8 ± 15.07 0.438 BMI (Kg/m 2 ) 30.5 ± 4.69 30.4 ± 4.64 0.523 Systolic blood pressure (mmHg) 131.9 ± 18.58 124.2 ± 10.57 < 0.001* Diastolic blood pressure (mmHg) 78 ± 7.98 74.1 ± 5.28 < 0.001* Data are presented as mean ± SD *: Significant as P value ≤ 0.05. BMI: Body mass index. HbA1c and creatinine were significantly lower after Ramadan than during Ramadan (P < 0.001). eGFR was significantly higher after Ramadan than during Ramadan (P < 0.001). Urine pus, Na, and K were insignificantly different during Ramadan and after Ramadan. Table 3 Table 3 Laboratory investigation during Ramadan and post-Ramadan of the studied patients During Ramadan After Ramadan P value HbA1c (%) 8.4 ± 1.68 7.9 ± 1.36 < 0.001* Creatinine (mg/dL) 1.1 ± 0.23 1 ± 0.22 < 0.001* eGFR (mL/min) 89.6 ± 26.14 95.2 ± 27.74 < 0.001* Urine pus (pus cells) 5.9 ± 4.01 6.1 ± 4.71 0.789 Serum Na (mEq/L) 138.7 ± 17.91 141.1 ± 2.64 0.303 Serum K (mmol/L) 4.3 ± 0.5 4.2 ± 0.38 0.256 Data are presented as mean ± SD *: Significant as P value ≤ 0.05. HbA1c: glycated hemoglobin. eGFR: estimated glomerular filtration rate. There was a significant negative correlation between age and HbA1c after Ramadan (r=-0.267, P = 0.037), eGFR during Ramadan (r = -0.667, P < 0.001), and eGFR after Ramadan (r =-0.684, P < 0.001) while there was no correlation between age and HbA1c during Ramadan. There was no correlation between the duration of DM and HbA1c during and after Ramadan. Table 4 Table 4 Correlation between age and (HbA1c and eGFR), and between duration of DM and HbA1c of the studied patients Age (years) HbA1c (%) During Ramadan r -0.239 P value 0.063 After Ramadan r -0.267 P value 0.037* eGFR (mg/dL) During Ramadan r -0.667 P value < 0.001* After Ramadan r -0.684 P value < 0.001* HbA1c (%) Duration of DM (years) During Ramadan r 0.082 P value 0.528 After Ramadan r 0.0427 P value 0.7439 *: Significant as P value ≤ 0.05. r: Pearson coefficient. HbA1c: glycated hemoglobin. eGFR: estimated glomerular filtration rate. DM: diabetes mellitus. HbA1c was significantly lower after Ramadan than during Ramadan in patients with IHD, HTN, PN, and CKD (P < 0.05). HbA1c during Ramadan and after Ramadan and Delta change between patients with IHD, HTN, PN, and CKD were insignificantly different. Table 5 Table 5 Relation between (ischemic heart disease, hypertension, and PN) and HbA1c of the studied patients During Ramadan After Ramadan P value # Delta change IHD (n = 10) 8.4 ± 1.53 7.8 ± 1.11 0.015* -0.6 ± 0.59 Hypertensive(n = 24) 8.4 ± 1.84 7.9 ± 1.53 < 0.001* -0.4 ± 0.5 PN(n = 24) 8.4 ± 1.44 7.9 ± 1.21 < 0.001* -0.5 ± 0.41 CKD(n = 4) 8.5 ± 2.18 7.9 ± 1.95 0.036* -0.6 ± 0.32 P value ## 1 0.996 - 0.829 Data are presented as mean ± SD *: Significant as P value ≤ 0.05. IHD: Ischemic heart disease. PN: Peripheral neuropathy. HbA1c: Heamoglobin A1c. CKD: Chronic kidney disrase. P value #: between during Ramadan and after Ramadan assessment. P value ##: between groups. Regarding safety, hypoglycaemia, dehydration, and DKA did not occur in any patient. Discussion Diabetes management throughout the fasting month of Ramadan is a delicate and difficult matter. Indeed, the majority of Muslims with diabetes continue to fast despite medical advice to the contrary [ 11 , 12 ] . However, there are significant hazards that fasting may entail [ 13 ] . Patients with diabetes who are at high or very high risk are recognized to be susceptible to hypoglycemia (especially during the day), undetected hyperglycemia (especially at night), dehydration, and DKA (especially at night) during the fasting period of Ramadan [ 14 ] . Hence, it is critical to choose an antidiabetic drug that is supported by scientific data and does not typically induce hypoglycemia, which would need the patient to interrupt their fast [ 15 ] . It has been demonstrated that SGLT2i is safe and effective when used in conjunction with other oral hypoglycemic agents, metformin, and intensive insulin treatment in several randomized controlled trials [ 16 – 19 ] . To the best of our knowledge, after intensive literature reading this is the first study to assess the efficacy and safety of the first use of SGLT2i during Ramadan fasting. The existing studies primarily focus on using SGLT2i before Ramadan fasting ​ [ 16 , 20 , 21 ] . Our results revealed that the differences in weight and BMI between during Ramadan and after Ramadan were not statistically significant. Systolic Blood Pressure (SPB) and Diastolic Blood Pressure (DPB) were significantly lower after Ramadan compared to during Ramadan. Both HbA1c levels and creatinine levels were significantly lower after Ramadan than during Ramadan. GFR was significantly higher after Ramadan than during Ramadan. Interestingly, for patients suffering from IHD, HTN, PN, and CKD, HbA1c was significantly lower after Ramadan than during Ramadan. In disagreement with our results, Sheikh et al. [ 22 ] noted that eGFR was significantly lower after Ramadan than pre-Ramadan. Also, SBP, DBP, HbA1c, and creatinine were comparable after Ramadan to pre-Ramadan. This difference may be attributed to the small sample size, 63.4% of the patients received empagliflozin, and patients with eGFR < 45 ml/min/1.73 m 2 were excluded. In contrary, Ahmed et al. [ 21 ] stated that SPB and DPB were insignificantly different between pre-Ramadan and after-Ramadan. This difference may be attributed to performing their study on patients with HbA1c ranging from 6.5–8.5% before Ramadan and eGFR > 60 ml/min. However, Pathan et al. [ 23 ] found that creatinine and eGFR were insignificant between after Ramadan and before Ramadan. This difference may be attributed to that all subjects who had an eGFR of less than 45 ml/min/1.73 m2 were excluded from the research. In contrast with our results, Abdelgadir et al. [ 20 ] noticed that SPB and DPB had insignificant differences between during Ramadan and after Ramadan. Creatinine and eGFR were higher after Ramadan than during Ramadan. This difference may be attributed to the use of a flash glucose monitoring system in blood glucose level management and monitoring, in which a sensor is applied on the upper arm. The sensor estimated glucose levels using the interstitial fluid under the skin records accurate glucose levels 24 hrs. a day. Every few minutes the sensor records glucose levels, 24 hours a day giving more accurate results [ 24 ] . In agreement with our results, Gad et al. [ 25 ] conducted a systematic review and meta-analysis that included five studies to evaluate the effects of Ramadan fasting on patients with T2DM treated with SGLT2i and showed that weight was insignificantly different between before Ramadan and after Ramadan, DPB and HbA1c were significantly lower after Ramadan than before Ramadan. Also our results were supported Sheikh et al. [ 22 ] who noted that in T2DM using SGLT2i, the weight was insignificantly different between pre-Ramadan and after Ramadan. Regarding weight, BMI, and HbA1c study performed by Ahmed et al. [ 21 ] was in consistent with our findings. Additionally, Pathan et al. [ 23 ] found that similar results of weight SBP, DBP (correct them, not SPB or DPB) and A1c in their study participants on empagliflozin. Moreover, Abdelgadir et al. [ 20 ] noticed that in T2DM using the SGLT2i group, weight was insignificant between before Ramadan and after Ramadan. HbA1c was lower after Ramadan than before Ramadan. In the present study, there was a significant negative correlation between age and HbA1c after Ramadan (r=-0.267, P = 0.037), eGFR during Ramadan (r = -0.667, P < 0.001), and eGFR after Ramadan (r =-0.684, P < 0.001). HbA1c levels after Ramadan reflected the average blood glucose control over the previous two to three months, including the fasting month. The age at which patients begin using SGLT2i could reflect the duration and progression of their diabetes condition [ 26 ] . Older patients might have more prolonged exposure to high glucose levels and potentially more complications or a longer history of diabetes management strategies [ 27 ] . Starting SGLT2i later might suggest a switch or addition in therapy, possibly reflecting a more aggressive approach to controlling HbA1c levels that were not adequately managed with previous therapies. SGLT2i at an older age is associated with better after Ramadan glycemic control [ 28 ] . Also, kidney function naturally declines with age due to physiological changes, reduced renal blood flow, and nephron loss. Older individuals are more likely to have pre-existing reduced eGFR, and thus the impact of SGLT2i affecting the kidneys might be more pronounced [ 29 , 30 ] . As limitations, the study performed was in a single center. Patients combine SGLT2i with insulin and secretagogues when fasting before Ramadan, so, further studies are necessary on patients receiving SGLT2i in combination with other oral hypoglycemic agents. Further studies comparing SGLT2i with other drugs are needed. Further studies to assess SGLT2i safety and efficacy in the long run. Conclusions: SGLT2i is effective and safe during Ramadan fasting with a significant reduction in SBP, DBP, HBA1c, and creatinine. Also, SGLT2i improves kidney function which is evidenced by the elevation of eGFR. Declarations Acknowledgements Author Contribution Hany Ahmed Mohamed Khalil: Research concert, design and data collection Sara Kasem Abdelal: Contributed in statistical analysis and revision of mkanuscript Ahmed Faysal El-Rawy: Data collection Alshimaa Lotfy Hamed Abodahab: Coresponding author, Writing, contributed in statistical analysis, and revision of the manuscript. Funding No funding or sponsorship was received for this study or publication of this article. None Data Availability No datasets were generated or analysed during the current study. Ethical Approval The research was conducted during Ramadan 2023 after the ethical approval of the Sohag University Hospital ethical committee in Egypt (approval code: Soh-Med-23-4-07PD). Informed written consent was obtained from the patient. The study was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments. Conflict of Interest None Authors: Hany Ahmed Mohamed Khalil, Sara Kasem Abdelal, Ahmed Faysal El-Rawy, Alshimaa Lotfy Hamed Abodahab, has nothing to disclose. References Shah J, Rahman Shalmani M, Abdikaxarovich S, Dikhanbay A (2023) Impact of fasting on human health during Ramadan. Int J Public Health Sci 12:1611–1625 Bouchareb S, Chrifou R, Bourik Z, Nijpels G, Hassanein M, Westerman MJ et al (2022) I am my own doctor: A qualitative study of the perspectives and decision-making process of Muslims with diabetes on Ramadan fasting. PLoS ONE 17:e0263088 Rahman S (2022) Ramadan fasting and its health benefits: What’s new? Open Access Maced J Med Sci 10:1329–1342 Tootee A, Larijan B (2021) Ramadan fasting and diabetes, latest evidence and technological advancements: 2021 update. J Diabetes Metab Disord 20:1085–1091 Hassanein M, Afandi B, Yakoob Ahmedani M, Mohammad Alamoudi R, Alawadi F, Bajaj HS et al (2022) Diabetes and Ramadan: Practical guidelines 2021. Diabetes Res Clin Pract 185:109185 Hassanein M, Echtay AS, Malek R, Omar M, Shaikh SS, Ekelund M et al (2018) Efficacy and safety analysis of insulin degludec/insulin aspart compared with biphasic insulin aspart 30: A phase 3, multicentre, international, open-label, randomised, treat-to-target trial in patients with type 2 diabetes fasting during Ramadan. Diabetes Res Clin Pract 135:218–226 Hassanein MM, Sahay R, Hafidh K, Djaballah K, Li H, Azar S et al (2019) Safety of lixisenatide versus sulfonylurea added to basal insulin treatment in people with type 2 diabetes mellitus who elect to fast during Ramadan (LixiRam): An international, randomized, open-label trial. Diabetes Res Clin Pract 150:331–341 Hassanein M, Buyukbese MA, Malek R, Pilorget V, Naqvi M, Berthou B et al (2020) Real-world safety and effectiveness of insulin glargine 300 U/mL in participants with type 2 diabetes who fast during Ramadan: The observational ORION study. Diabetes Res Clin Pract 166:108189 Hassanein M, Malek R, Shaltout I, Sahay RK, Buyukbese MA, Djaballah K et al (2023) Real-world safety and effectiveness of iGlarLixi in people with type 2 diabetes who fast during Ramadan: The SoliRam observational study. Diabetes Metab Syndr 17:102707 Srinivas N, Sarnaik MK, Modi S, Pisipati Y, Vaidya S, Syed Gaggatur N et al (2021) Sodium-Glucose Cotransporter 2 (SGLT-2) Inhibitors: Delving Into the Potential Benefits of Cardiorenal Protection Beyond the Treatment of Type-2 Diabetes Mellitus. Cureus 13:e16868 Ibrahim M, Barker MM, Ahmad E, Ahmed A, Annabi FA, Ba-Essa EM et al (2023) Optimizing Ramadan fasting: A randomised controlled trial for people with type 2 diabetes during Ramadan applying the principles of the ADA/EASD consensus. Diabetes Metab Res Rev 39:e3604 Ibrahim M, Davies MJ, Ahmad E, Annabi FA, Eckel RH, Ba-Essa EM et al (2020) Recommendations for management of diabetes during Ramadan: update 2020, applying the principles of the ADA/EASD consensus. BMJ Open Diabetes Res Care. ;8 Majid A, Osama M, Noman M, Nisa U, Haider I (2023) Effect of Ramadan fasting on body weight and body mass index (BMI) in public sector undergraduate medical students of Peshawar. Pak J Med Sci 39:662–666 Noor SK, Alutol MT, FadAllah FSA, Ahmed AA, Osman SA, Badi S et al (2023) Risk factors associated with fasting during Ramadan among individuals with diabetes according to IDF-DAR risk score in Atbara city, Sudan: Cross-sectional hospital-based study. Diabetes Metab Syndr 17:102743 Builes-Montaño C, Wandurraga E, Ramírez A, Ordóñez JE (2023) Simplification of Complex Insulin Regimens with IdegLira in People with Type 2 Diabetes: Literature Review and Clinical Recommendations. Diabetes Ther 14:1959–1976 Bashier A, Khalifa AA, Abdelgadir EI, Al Saeed MA, Al Qaysi AA, Bayati MBA et al (2018) Safety of sodium-glucose cotransporter 2 inhibitors (SGLT2-i) during the month of ramadan in muslim patients with type 2 diabetes. Oman Med J 33:104–110 John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A et al (2016) Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract 70:775–785 Bailey CJ, Morales Villegas EC, Woo V, Tang W, Ptaszynska A, List JF (2015) Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial. Diabet Med 32:531–541 Wilding JP, Woo V, Rohwedder K, Sugg J, Parikh S (2014) Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab 16:124–136 Abdelgadir E, Rashid F, Bashier A, Al Saeed M, Khalifa A, Alawadi F et al (2019) Use of flash glucose monitoring system in assessing safety of the SGLT2 inhibitors during Ramadan fasting in high risk insulin treated patients with type 2 diabetes. Diabetes Metab Syndr 13:2927–2932 Ahmed I, Raja UY, Wahab MU, Rehman T, Ishtiaq O, Aamir AH et al (2022) Efficacy and safety of combination of empagliflozin and metformin with combination of sitagliptin and metformin during Ramadan: an observational study. BMC Endocr Disord 22:247 Sheikh A, Das B, Sattar S, Islam N (2023) Safety of sodium-glucose cotransporter 2 inhibitors (SGLT2i) during the month of Ramadan in patients with type 2 diabetes mellitus in Pakistani population-an observational study from a tertiary care center in Karachi. Endocrine 80:64–70 Pathan MDF, Akter N, Selim S, Saifuddin M, Qureshi NK, Kamrul-Hasan ABM et al (2022) Efficacy and safety of empagliflozin in patients with type 2 diabetes mellitus fasting during ramadan: A real-world study from bangladesh. Diabetes Metab Syndr Obes 15:4011–4021 Krakauer M, Botero JF, Lavalle-González FJ, Proietti A, Barbieri DE (2021) A review of flash glucose monitoring in type 2 diabetes. Diabetol Metab Syndr 13:42 Gad H, Al-Nassr N, Mohammed I, Khan A, MacDonald R, Mussleman P et al (2022) Effect of Ramadan fasting in patients with type 2 diabetes mellitus treated with sodium-glucose cotransporter 2 inhibitors: A systematic review and meta-analysis. J Diabetes Investig 13:822–829 Tumminia A, Graziano M, Vinciguerra F, Lomonaco A, Frittita L (2021) Efficacy, renal safety and tolerability of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in elderly patients with type 2 diabetes: a real-world experience. Prim Care Diabetes 15:283–288 Huang ES, Laiteerapong N, Liu JY, John PM, Moffet HH, Karter AJ (2014) Rates of complications and mortality in older patients with diabetes mellitus: the diabetes and aging study. JAMA Intern Med 174:251–258 Bellary S, Barnett AH (2023) SGLT2 inhibitors in older adults: overcoming the age barrier. Lancet Health Longev 4:e127–e8 Ravender R, Roumelioti M-E, Schmidt DW, Unruh ML, Argyropoulos C (2023) Chronic kidney disease in the elderly patient with diabetes Chatzikyrkou C, Scurt F, Clajus C, Roumeliotis S, Mertens P, Haller H et al (eds) (2019) Predictors of Outcomes of Living Kidney Donation: Impact of Sex, Age and Preexistent Hypertension. Transplantation Proceedings; : Elsevier Additional Declarations There is NO conflict of interest to disclose Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4473992","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":326142557,"identity":"8eb00e99-cc5b-4b6b-b7e8-3ca59180b3b3","order_by":0,"name":"Alshimaa Abodahab","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA40lEQVRIiWNgGAWjYDACdgY2hgQgzc/MfICBsYEYLcxQLZLtbQkkaAEBgzNnDIjTwt/M/uzBwxw7eYYbOd8kfu6wkWNgP3x0Az4tEod5zA0StyUbNs7I3SbZeybNmIEnLe0GXmsO87BJJG5jZmyWyN0mwdt2OLFBgscMrxb5w+zPgFrq7dskcp5J/iVGi8FhBjOglsOJPTxn2KSJssXwMA9Iy/HkGextxtaybWnGbIT8Ine8/Znkz23VtvsPMz+8+bbNRo6f/fAx/N5HAiwSIJKNWOUgwPyBFNWjYBSMglEwcgAAZShJmNoMZAsAAAAASUVORK5CYII=","orcid":"","institution":"faculty of medicine, Sohag University","correspondingAuthor":true,"prefix":"","firstName":"Alshimaa","middleName":"","lastName":"Abodahab","suffix":""},{"id":326142558,"identity":"55cb0d8c-e269-402a-b542-d2aa39f80932","order_by":1,"name":"Hany Khalil","email":"","orcid":"","institution":"Faculty of medicine, Sohag University","correspondingAuthor":false,"prefix":"","firstName":"Hany","middleName":"","lastName":"Khalil","suffix":""},{"id":326142559,"identity":"021437f1-9690-402d-b8ad-33e7dade1394","order_by":2,"name":"Sara Abdelal","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Sara","middleName":"","lastName":"Abdelal","suffix":""},{"id":326142560,"identity":"f0b5ef14-61ba-4c6e-82b7-72a0e68c3045","order_by":3,"name":"Ahmed El-Rawy","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Ahmed","middleName":"","lastName":"El-Rawy","suffix":""},{"id":326142561,"identity":"88df1831-ae5f-4e9f-9151-eb42018e8420","order_by":4,"name":"Alshimaa Abodahab","email":"","orcid":"","institution":"faculty of medicine, Sohag University","correspondingAuthor":false,"prefix":"","firstName":"Alshimaa","middleName":"","lastName":"Abodahab","suffix":""}],"badges":[],"createdAt":"2024-05-24 18:30:06","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4473992/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4473992/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":71540684,"identity":"9cd816d5-bb12-4397-a72f-34c77fb566d3","added_by":"auto","created_at":"2024-12-16 14:38:42","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":625292,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4473992/v1/f21ed327-cdf5-42ad-adda-978d28932574.pdf"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose","formattedTitle":"First-time Usage of SGLT2 Inhibitors in Patients with Type 2 Diabetes Who Are Fasting Ramadan: Efficacy and Safety","fulltext":[{"header":"Introduction:","content":"\u003cp\u003eMuslims worldwide observe a continuous fast from dawn to dusk in the holy month of Ramadan. Ramadan fasting must necessitate substantial alterations in the intake and frequency of meals. All Muslims who fast the holy month of Ramadan have metabolic changes as a result of these alterations \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e.Many Muslim patients with acute or chronic medical conditions prefer fasting. Religiosity, personal beliefs, and spirituality are crucial factors of the social determinants that impact health-related behaviors and treatment adherence of patients \u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eNevertheless, Fasting is a deeply respected religious practice observed throughout the holy month of Ramadan, and devout Muslim individuals persist in fasting even when their healthcare doctors advise against it. In 2019, globally, approximately, 460\u0026nbsp;million people were living with diabetes and approximately, 148\u0026nbsp;million Muslim people were living with diabetes and this number is increasing \u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. It has been estimated that worldwide 116\u0026nbsp;million muslim patients with diabetes fast, fasting can significantly affect blood glucose levels and overall metabolism. Patients with type 2 diabetes mellitus (T2DM) need to carefully manage their condition during fasting to avoid acute complications like hypoglycemia or hyperglycemia \u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eBefore Ramadan, several clinical studies, including those using insulin, glucagon-like peptide-1 agonists, sulphonylureas, and dipeptidyl peptidase inhibitors, evaluated the safety of pharmacological diabetic therapies \u003csup\u003e[\u003cspan additionalcitationids=\"CR7 CR8\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eSodium-glucose cotransporter 2 inhibitors (SGLT2i) represent the most current class development class of oral anti-diabetic drugs having cardiovascular and renal advantages. SGLT2i inhibits the proximal tubule of the kidney's glucose absorption, reducing blood sugar levels. At now, the predominant use of SGLT2i is as anti-diabetic drugs; nevertheless, their benefits extend well beyond mere glycemic regulation \u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe study aimed to assess the efficacy and safety of the use of SGLT2i for the first time during Ramadan fasting. So, we can give this drug without delay in Ramadan.\u003c/p\u003e"},{"header":"Methods:","content":"\u003cp\u003eThis prospective, cohort study was conducted on 61 Egyptian Muslim patients with T2DM, 18 years or older, both sexes, intending to fast during Ramadan and treated with SGLT2 inhibitors (empagliflozin, or dapagliflozin) as an add-on to metformin or another oral hypoglycemic agent.\u003c/p\u003e \u003cp\u003e The research was conducted during Ramadan 2023 after the ethical approval of the Sohag University Hospital ethical committee in Egypt (approval code: Soh-Med-23-4-07PD). Informed written consent was obtained from the patient. The study was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments.\u003c/p\u003e \u003cp\u003eThe indications of adding SGLT2 inhibitors were; first to more control of blood sugar and second for cardio-renal benefits especially in patients with ischemia or renal affection.\u003c/p\u003e \u003cp\u003eExclusion criteria were chronic liver disease (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase blood levels over twice the normal value upper limit), chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) of below 25 ml/min/1.73 m\u003csup\u003e2\u003c/sup\u003e], renal dialysis and ketoacidosis during the previous six months, prior diagnosis of cancer within the previous three years, strokes (including transient ischemic attack) and diabetic foot infection, non-traumatic even minor amputation, or gangrene. Also, pregnant, or lactating women and prior occurrence of recurrent urinary tract infections as well as individuals who ceased taking SGLT2i throughout the holy month of Ramadan or fasted for less than 15 days were all excluded.\u003c/p\u003e \u003cp\u003eAll patients were subjected to full history taken [duration of DM, current medication and other comorbid diseases like hypertension (HTN), ischemic heart disease (IHD), chronic kidney disease (CKD), peripheral neuropathy (PN), dyslipidemia, atherosclerotic cardiovascular diseases, the time of hypoglycemia, the number of symptomatic and recorded episodes of hypoglycemia, the number of days fasting, any hospitalizations required to treat hypoglycemia and hyperglycemia, acute dehydration, or diabetic ketoacidosis (DKA), and any complaints of excessive and unusual thirst)] and clinical assessment [weight, body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)].\u003c/p\u003e \u003cp\u003eWe assessed HbA1c, creatinine, eGFR, urine analysis, and serum electrolytes (Na and K) during and after Ramadan assessments were obtained after six weeks.\u003c/p\u003e \u003cp\u003eSulfonylureas (SU) or other oral hypoglycemic medications were modified in observance of Ramadan, and SGLT2i dosing began after Iftar time. Diabetes education related to Ramadan was provided to participants by standard protocols. Awareness and identification of warning indicators of hypoglycemia were assessed and reinforced during Ramadan evaluation. The dosage of SGLT2i (empagliflozin or dapagliflozin) and oral anti-diabetic medicines were provided.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eSPSS V24 (IBM Inc., Chicago, IL, USA) was used for statistical analysis. The mean and standard deviation (SD) were used to represent quantitative variables which were compared by the paired Student t-test. The frequency and percentage were used to represent qualitative variables. The Pearson correlation was used to do the correlation between various variables. A two-tailed P value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results:","content":"\u003cp\u003eThe mean value (\u0026plusmn;\u0026thinsp;SD) of age was 50.5 (\u0026plusmn;\u0026thinsp;11.21) years. There were 25 (40.98%) male patients. The mean value (\u0026plusmn;\u0026thinsp;SD) of the duration of DM was 5.8 (\u0026plusmn;\u0026thinsp;4.9) years. Hypertension was present in 24 (39.34%) patients. Ischemic heart disease was present in 10 (16.39%) patients. CKD was present in 24 (39.34%) patients. PN was present in 24 (39.34%) patients. 33 (54.1%) patients were receiving dapagliflozin and 36 (59.02%) patients were receiving empagliflozin. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic data, medical history, and SGLT2i of the studied patients\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e Nin\u0026thinsp;=\u0026thinsp;61)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge (years)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50.5\u0026thinsp;\u0026plusmn;\u0026thinsp;11.21\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eSex\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eMale\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25 (40.98%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eFemale\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36 (59.02%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDuration of DM (years)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.8\u0026thinsp;\u0026plusmn;\u0026thinsp;4.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003eMedical history\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHypertension\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24 (39.34%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eIHD\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (16.39%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eCKD\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24 (39.34%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003ePN\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24 (39.34%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eType of SGLT2i\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eDapagliflozin\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33 (54.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eEmpagliflozin\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28 (45.9%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003eData are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD or frequency (%). DM: Diabetes mellitus, IHD: Ischemic heart disease. CKD: Chronic kidney disease. PN: Parental nutrition. SGLT2i: Sodium-glucose cotransporter-2.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eWeight and BMI were insignificantly different between during Ramadan and after Ramadan. Systolic and diastolic blood pressures were significantly lower after Ramadan than during Ramadan (P\u0026thinsp;\u003cb\u003e\u0026lt;\u003c/b\u003e\u0026thinsp;0.001). Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eWeight, BMI, and blood pressure of the studied patients\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDuring Ramadan (n\u0026thinsp;=\u0026thinsp;61)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAfter Ramadan (n\u0026thinsp;=\u0026thinsp;61)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWeight (Kg)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e85\u0026thinsp;\u0026plusmn;\u0026thinsp;15.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e84.8\u0026thinsp;\u0026plusmn;\u0026thinsp;15.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.438\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBMI (Kg/m\u003c/b\u003e\u003csup\u003e\u003cb\u003e2\u003c/b\u003e\u003c/sup\u003e\u003cb\u003e)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e30.5\u0026thinsp;\u0026plusmn;\u0026thinsp;4.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e30.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.523\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSystolic blood pressure (mmHg)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e131.9\u0026thinsp;\u0026plusmn;\u0026thinsp;18.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e124.2\u0026thinsp;\u0026plusmn;\u0026thinsp;10.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDiastolic blood pressure (mmHg)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e78\u0026thinsp;\u0026plusmn;\u0026thinsp;7.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e74.1\u0026thinsp;\u0026plusmn;\u0026thinsp;5.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eData are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD *: Significant as P value\u0026thinsp;\u0026le;\u0026thinsp;0.05. BMI: Body mass index.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eHbA1c and creatinine were significantly lower after Ramadan than during Ramadan (P\u0026thinsp;\u003cb\u003e\u0026lt;\u003c/b\u003e\u0026thinsp;0.001). eGFR was significantly higher after Ramadan than during Ramadan (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Urine pus, Na, and K were insignificantly different during Ramadan and after Ramadan. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eLaboratory investigation during Ramadan and post-Ramadan of the studied patients\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDuring Ramadan\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAfter Ramadan\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHbA1c (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e8.4\u0026thinsp;\u0026plusmn;\u0026thinsp;1.68\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e7.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCreatinine (mg/dL)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e1.1\u0026thinsp;\u0026plusmn;\u0026thinsp;0.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e1\u0026thinsp;\u0026plusmn;\u0026thinsp;0.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eeGFR (mL/min)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e89.6\u0026thinsp;\u0026plusmn;\u0026thinsp;26.14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e95.2\u0026thinsp;\u0026plusmn;\u0026thinsp;27.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eUrine pus (pus cells)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e5.9\u0026thinsp;\u0026plusmn;\u0026thinsp;4.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e6.1\u0026thinsp;\u0026plusmn;\u0026thinsp;4.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.789\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSerum Na (mEq/L)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e138.7\u0026thinsp;\u0026plusmn;\u0026thinsp;17.91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e141.1\u0026thinsp;\u0026plusmn;\u0026thinsp;2.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.303\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSerum K (mmol/L)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e4.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e4.2\u0026thinsp;\u0026plusmn;\u0026thinsp;0.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.256\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eData are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD *: Significant as P value\u0026thinsp;\u0026le;\u0026thinsp;0.05. HbA1c: glycated hemoglobin. eGFR: estimated glomerular filtration rate.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThere was a significant negative correlation between age and HbA1c after Ramadan (r=-0.267, P\u0026thinsp;=\u0026thinsp;0.037), eGFR during Ramadan (r = -0.667, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), and eGFR after Ramadan (r =-0.684, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001) while there was no correlation between age and HbA1c during Ramadan. There was no correlation between the duration of DM and HbA1c during and after Ramadan. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCorrelation between age and (HbA1c and eGFR), and between duration of DM and HbA1c of the studied patients\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003eHbA1c\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003e(%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eDuring Ramadan\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003er\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-0.239\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eP value\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.063\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eAfter Ramadan\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003er\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-0.267\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eP value\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.037*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003eeGFR (mg/dL)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eDuring Ramadan\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003er\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-0.667\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eP value\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eAfter Ramadan\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003er\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-0.684\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eP value\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003eHbA1c (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003eDuration of DM (years)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eDuring Ramadan\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003er\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.082\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eP value\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.528\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eAfter Ramadan\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003er\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0427\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eP value\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.7439\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e*: Significant as P value\u0026thinsp;\u0026le;\u0026thinsp;0.05. r: Pearson coefficient. HbA1c: glycated hemoglobin. eGFR: estimated glomerular filtration rate. DM: diabetes mellitus.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eHbA1c was significantly lower after Ramadan than during Ramadan in patients with IHD, HTN, PN, and CKD (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05). HbA1c during Ramadan and after Ramadan and Delta change between patients with IHD, HTN, PN, and CKD were insignificantly different. Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eRelation between (ischemic heart disease, hypertension, and PN) and HbA1c of the studied patients\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDuring Ramadan\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAfter Ramadan\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value \u003csup\u003e#\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eDelta change\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eIHD (n\u0026thinsp;=\u0026thinsp;10)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.4\u0026thinsp;\u0026plusmn;\u0026thinsp;1.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.8\u0026thinsp;\u0026plusmn;\u0026thinsp;1.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.015*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.6\u0026thinsp;\u0026plusmn;\u0026thinsp;0.59\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHypertensive(n\u0026thinsp;=\u0026thinsp;24)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.4\u0026thinsp;\u0026plusmn;\u0026thinsp;1.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.4\u0026thinsp;\u0026plusmn;\u0026thinsp;0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePN(n\u0026thinsp;=\u0026thinsp;24)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.4\u0026thinsp;\u0026plusmn;\u0026thinsp;1.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.5\u0026thinsp;\u0026plusmn;\u0026thinsp;0.41\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCKD(n\u0026thinsp;=\u0026thinsp;4)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.036*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.6\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eP value\u003c/b\u003e \u003csup\u003e\u003cb\u003e##\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.996\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.829\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eData are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD *: Significant as P value\u0026thinsp;\u0026le;\u0026thinsp;0.05. IHD: Ischemic heart disease. PN: Peripheral neuropathy. HbA1c: Heamoglobin A1c. CKD: Chronic kidney disrase. P value #: between during Ramadan and after Ramadan assessment. P value ##: between groups.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eRegarding safety, hypoglycaemia, dehydration, and DKA did not occur in any patient.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eDiabetes management throughout the fasting month of Ramadan is a delicate and difficult matter. Indeed, the majority of Muslims with diabetes continue to fast despite medical advice to the contrary \u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e. However, there are significant hazards that fasting may entail \u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003ePatients with diabetes who are at high or very high risk are recognized to be susceptible to hypoglycemia (especially during the day), undetected hyperglycemia (especially at night), dehydration, and DKA (especially at night) during the fasting period of Ramadan \u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/sup\u003e. Hence, it is critical to choose an antidiabetic drug that is supported by scientific data and does not typically induce hypoglycemia, which would need the patient to interrupt their fast \u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIt has been demonstrated that SGLT2i is safe and effective when used in conjunction with other oral hypoglycemic agents, metformin, and intensive insulin treatment in several randomized controlled trials \u003csup\u003e[\u003cspan additionalcitationids=\"CR17 CR18\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eTo the best of our knowledge, after intensive literature reading this is the first study to assess the efficacy and safety of the first use of SGLT2i during Ramadan fasting. The existing studies primarily focus on using SGLT2i before Ramadan fasting ​\u003csup\u003e[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eOur results revealed that the differences in weight and BMI between during Ramadan and after Ramadan were not statistically significant. Systolic Blood Pressure (SPB) and Diastolic Blood Pressure (DPB) were significantly lower after Ramadan compared to during Ramadan. Both HbA1c levels and creatinine levels were significantly lower after Ramadan than during Ramadan. GFR was significantly higher after Ramadan than during Ramadan. Interestingly, for patients suffering from IHD, HTN, PN, and CKD, HbA1c was significantly lower after Ramadan than during Ramadan.\u003c/p\u003e \u003cp\u003eIn disagreement with our results, Sheikh et al. \u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e noted that eGFR was significantly lower after Ramadan than pre-Ramadan. Also, SBP, DBP, HbA1c, and creatinine were comparable after Ramadan to pre-Ramadan. This difference may be attributed to the small sample size, 63.4% of the patients received empagliflozin, and patients with eGFR\u0026thinsp;\u0026lt;\u0026thinsp;45 ml/min/1.73 m\u003csup\u003e2\u003c/sup\u003e were excluded.\u003c/p\u003e \u003cp\u003eIn contrary, Ahmed et al. \u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/sup\u003e stated that SPB and DPB were insignificantly different between pre-Ramadan and after-Ramadan. This difference may be attributed to performing their study on patients with HbA1c ranging from 6.5\u0026ndash;8.5% before Ramadan and eGFR\u0026thinsp;\u0026gt;\u0026thinsp;60 ml/min.\u003c/p\u003e \u003cp\u003eHowever, Pathan et al. \u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e found that creatinine and eGFR were insignificant between after Ramadan and before Ramadan. This difference may be attributed to that all subjects who had an eGFR of less than 45 ml/min/1.73 m2 were excluded from the research.\u003c/p\u003e \u003cp\u003eIn contrast with our results, Abdelgadir et al. \u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e noticed that SPB and DPB had insignificant differences between during Ramadan and after Ramadan. Creatinine and eGFR were higher after Ramadan than during Ramadan. This difference may be attributed to the use of a flash glucose monitoring system in blood glucose level management and monitoring, in which a sensor is applied on the upper arm. The sensor estimated glucose levels using the interstitial fluid under the skin records accurate glucose levels 24 hrs. a day. Every few minutes the sensor records glucose levels, 24 hours a day giving more accurate results \u003csup\u003e[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn agreement with our results, Gad et al. \u003csup\u003e[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]\u003c/sup\u003e conducted a systematic review and meta-analysis that included five studies to evaluate the effects of Ramadan fasting on patients with T2DM treated with SGLT2i and showed that weight was insignificantly different between before Ramadan and after Ramadan, DPB and HbA1c were significantly lower after Ramadan than before Ramadan.\u003c/p\u003e \u003cp\u003eAlso our results were supported Sheikh et al. \u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e who noted that in T2DM using SGLT2i, the weight was insignificantly different between pre-Ramadan and after Ramadan.\u003c/p\u003e \u003cp\u003eRegarding weight, BMI, and HbA1c study performed by Ahmed et al. \u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/sup\u003e was in consistent with our findings.\u003c/p\u003e \u003cp\u003eAdditionally, Pathan et al. \u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e found that similar results of weight SBP, DBP (correct them, not SPB or DPB) and A1c in their study participants on empagliflozin.\u003c/p\u003e \u003cp\u003eMoreover, Abdelgadir et al. \u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e noticed that in T2DM using the SGLT2i group, weight was insignificant between before Ramadan and after Ramadan. HbA1c was lower after Ramadan than before Ramadan.\u003c/p\u003e \u003cp\u003eIn the present study, there was a significant negative correlation between age and HbA1c after Ramadan (r=-0.267, P\u0026thinsp;=\u0026thinsp;0.037), eGFR during Ramadan (r = -0.667, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), and eGFR after Ramadan (r =-0.684, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e \u003cp\u003eHbA1c levels after Ramadan reflected the average blood glucose control over the previous two to three months, including the fasting month. The age at which patients begin using SGLT2i could reflect the duration and progression of their diabetes condition \u003csup\u003e[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]\u003c/sup\u003e. Older patients might have more prolonged exposure to high glucose levels and potentially more complications or a longer history of diabetes management strategies \u003csup\u003e[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]\u003c/sup\u003e. Starting SGLT2i later might suggest a switch or addition in therapy, possibly reflecting a more aggressive approach to controlling HbA1c levels that were not adequately managed with previous therapies. SGLT2i at an older age is associated with better after Ramadan glycemic control \u003csup\u003e[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAlso, kidney function naturally declines with age due to physiological changes, reduced renal blood flow, and nephron loss. Older individuals are more likely to have pre-existing reduced eGFR, and thus the impact of SGLT2i affecting the kidneys might be more pronounced \u003csup\u003e[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAs limitations, the study performed was in a single center. Patients combine SGLT2i with insulin and secretagogues when fasting before Ramadan, so, further studies are necessary on patients receiving SGLT2i in combination with other oral hypoglycemic agents. Further studies comparing SGLT2i with other drugs are needed. Further studies to assess SGLT2i safety and efficacy in the long run.\u003c/p\u003e"},{"header":"Conclusions:","content":"\u003cp\u003eSGLT2i is effective and safe during Ramadan fasting with a significant reduction in SBP, DBP, HBA1c, and creatinine. Also, SGLT2i improves kidney function which is evidenced by the elevation of eGFR.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contribution\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHany Ahmed Mohamed Khalil: Research concert, design and data collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;Sara Kasem Abdelal: Contributed in statistical analysis and revision of mkanuscript\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;Ahmed Faysal El-Rawy: Data collection\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;Alshimaa Lotfy Hamed Abodahab: Coresponding author, Writing, contributed in statistical analysis, and revision of the manuscript.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNo funding or sponsorship was received for this study or publication of this article.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo datasets were generated or analysed during the current study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe research was conducted during Ramadan 2023 after\u0026nbsp;the ethical approval of the Sohag University Hospital ethical committee in Egypt (approval code: Soh-Med-23-4-07PD). Informed written consent was obtained from the patient.\u0026nbsp;The study was conducted in accordance with the Helsinki Declaration of 1964 and its later\u0026nbsp;amendments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003cp\u003eAuthors: Hany Ahmed Mohamed Khalil, Sara Kasem Abdelal, Ahmed Faysal El-Rawy, Alshimaa Lotfy Hamed Abodahab, has nothing to disclose.\u003cbr\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eShah J, Rahman Shalmani M, Abdikaxarovich S, Dikhanbay A (2023) Impact of fasting on human health during Ramadan. Int J Public Health Sci 12:1611\u0026ndash;1625\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBouchareb S, Chrifou R, Bourik Z, Nijpels G, Hassanein M, Westerman MJ et al (2022) I am my own doctor: A qualitative study of the perspectives and decision-making process of Muslims with diabetes on Ramadan fasting. PLoS ONE 17:e0263088\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRahman S (2022) Ramadan fasting and its health benefits: What\u0026rsquo;s new? Open Access Maced J Med Sci 10:1329\u0026ndash;1342\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTootee A, Larijan B (2021) Ramadan fasting and diabetes, latest evidence and technological advancements: 2021 update. J Diabetes Metab Disord 20:1085\u0026ndash;1091\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHassanein M, Afandi B, Yakoob Ahmedani M, Mohammad Alamoudi R, Alawadi F, Bajaj HS et al (2022) Diabetes and Ramadan: Practical guidelines 2021. Diabetes Res Clin Pract 185:109185\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHassanein M, Echtay AS, Malek R, Omar M, Shaikh SS, Ekelund M et al (2018) Efficacy and safety analysis of insulin degludec/insulin aspart compared with biphasic insulin aspart 30: A phase 3, multicentre, international, open-label, randomised, treat-to-target trial in patients with type 2 diabetes fasting during Ramadan. Diabetes Res Clin Pract 135:218\u0026ndash;226\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHassanein MM, Sahay R, Hafidh K, Djaballah K, Li H, Azar S et al (2019) Safety of lixisenatide versus sulfonylurea added to basal insulin treatment in people with type 2 diabetes mellitus who elect to fast during Ramadan (LixiRam): An international, randomized, open-label trial. Diabetes Res Clin Pract 150:331\u0026ndash;341\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHassanein M, Buyukbese MA, Malek R, Pilorget V, Naqvi M, Berthou B et al (2020) Real-world safety and effectiveness of insulin glargine 300 U/mL in participants with type 2 diabetes who fast during Ramadan: The observational ORION study. Diabetes Res Clin Pract 166:108189\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHassanein M, Malek R, Shaltout I, Sahay RK, Buyukbese MA, Djaballah K et al (2023) Real-world safety and effectiveness of iGlarLixi in people with type 2 diabetes who fast during Ramadan: The SoliRam observational study. Diabetes Metab Syndr 17:102707\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSrinivas N, Sarnaik MK, Modi S, Pisipati Y, Vaidya S, Syed Gaggatur N et al (2021) Sodium-Glucose Cotransporter 2 (SGLT-2) Inhibitors: Delving Into the Potential Benefits of Cardiorenal Protection Beyond the Treatment of Type-2 Diabetes Mellitus. Cureus 13:e16868\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIbrahim M, Barker MM, Ahmad E, Ahmed A, Annabi FA, Ba-Essa EM et al (2023) Optimizing Ramadan fasting: A randomised controlled trial for people with type 2 diabetes during Ramadan applying the principles of the ADA/EASD consensus. Diabetes Metab Res Rev 39:e3604\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIbrahim M, Davies MJ, Ahmad E, Annabi FA, Eckel RH, Ba-Essa EM et al (2020) Recommendations for management of diabetes during Ramadan: update 2020, applying the principles of the ADA/EASD consensus. BMJ Open Diabetes Res Care. ;8\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMajid A, Osama M, Noman M, Nisa U, Haider I (2023) Effect of Ramadan fasting on body weight and body mass index (BMI) in public sector undergraduate medical students of Peshawar. Pak J Med Sci 39:662\u0026ndash;666\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNoor SK, Alutol MT, FadAllah FSA, Ahmed AA, Osman SA, Badi S et al (2023) Risk factors associated with fasting during Ramadan among individuals with diabetes according to IDF-DAR risk score in Atbara city, Sudan: Cross-sectional hospital-based study. Diabetes Metab Syndr 17:102743\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBuiles-Monta\u0026ntilde;o C, Wandurraga E, Ram\u0026iacute;rez A, Ord\u0026oacute;\u0026ntilde;ez JE (2023) Simplification of Complex Insulin Regimens with IdegLira in People with Type 2 Diabetes: Literature Review and Clinical Recommendations. Diabetes Ther 14:1959\u0026ndash;1976\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBashier A, Khalifa AA, Abdelgadir EI, Al Saeed MA, Al Qaysi AA, Bayati MBA et al (2018) Safety of sodium-glucose cotransporter 2 inhibitors (SGLT2-i) during the month of ramadan in muslim patients with type 2 diabetes. Oman Med J 33:104\u0026ndash;110\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJohn M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A et al (2016) Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract 70:775\u0026ndash;785\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBailey CJ, Morales Villegas EC, Woo V, Tang W, Ptaszynska A, List JF (2015) Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial. Diabet Med 32:531\u0026ndash;541\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWilding JP, Woo V, Rohwedder K, Sugg J, Parikh S (2014) Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab 16:124\u0026ndash;136\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbdelgadir E, Rashid F, Bashier A, Al Saeed M, Khalifa A, Alawadi F et al (2019) Use of flash glucose monitoring system in assessing safety of the SGLT2 inhibitors during Ramadan fasting in high risk insulin treated patients with type 2 diabetes. Diabetes Metab Syndr 13:2927\u0026ndash;2932\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAhmed I, Raja UY, Wahab MU, Rehman T, Ishtiaq O, Aamir AH et al (2022) Efficacy and safety of combination of empagliflozin and metformin with combination of sitagliptin and metformin during Ramadan: an observational study. BMC Endocr Disord 22:247\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSheikh A, Das B, Sattar S, Islam N (2023) Safety of sodium-glucose cotransporter 2 inhibitors (SGLT2i) during the month of Ramadan in patients with type 2 diabetes mellitus in Pakistani population-an observational study from a tertiary care center in Karachi. Endocrine 80:64\u0026ndash;70\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePathan MDF, Akter N, Selim S, Saifuddin M, Qureshi NK, Kamrul-Hasan ABM et al (2022) Efficacy and safety of empagliflozin in patients with type 2 diabetes mellitus fasting during ramadan: A real-world study from bangladesh. Diabetes Metab Syndr Obes 15:4011\u0026ndash;4021\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKrakauer M, Botero JF, Lavalle-Gonz\u0026aacute;lez FJ, Proietti A, Barbieri DE (2021) A review of flash glucose monitoring in type 2 diabetes. Diabetol Metab Syndr 13:42\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGad H, Al-Nassr N, Mohammed I, Khan A, MacDonald R, Mussleman P et al (2022) Effect of Ramadan fasting in patients with type 2 diabetes mellitus treated with sodium-glucose cotransporter 2 inhibitors: A systematic review and meta-analysis. J Diabetes Investig 13:822\u0026ndash;829\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTumminia A, Graziano M, Vinciguerra F, Lomonaco A, Frittita L (2021) Efficacy, renal safety and tolerability of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in elderly patients with type 2 diabetes: a real-world experience. Prim Care Diabetes 15:283\u0026ndash;288\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHuang ES, Laiteerapong N, Liu JY, John PM, Moffet HH, Karter AJ (2014) Rates of complications and mortality in older patients with diabetes mellitus: the diabetes and aging study. JAMA Intern Med 174:251\u0026ndash;258\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBellary S, Barnett AH (2023) SGLT2 inhibitors in older adults: overcoming the age barrier. Lancet Health Longev 4:e127\u0026ndash;e8\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRavender R, Roumelioti M-E, Schmidt DW, Unruh ML, Argyropoulos C (2023) Chronic kidney disease in the elderly patient with diabetes\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChatzikyrkou C, Scurt F, Clajus C, Roumeliotis S, Mertens P, Haller H et al (eds) (2019) Predictors of Outcomes of Living Kidney Donation: Impact of Sex, Age and Preexistent Hypertension. Transplantation Proceedings; : Elsevier\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Efficacy, Empagliflozin, Dapagliflozin, Ramadan Fasting, Safety, SGLT2 inhibitors, Type 2 Diabetes Mellitus","lastPublishedDoi":"10.21203/rs.3.rs-4473992/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4473992/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e \u003cb\u003eIntroduction\u003c/b\u003e: Ramadan fasting claims a necessary role in management of diabetes. Many people with type 2 diabetes insist on fasting during the holy month of Ramadan, which represents a challenge to their physicians to provide balance between preventing hypoglycemia or diabetic ketoacidosis and good control of hyperglycemia with its short- and long-term complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a glucose-lowering therapy for type 2 diabetes which are generally well tolerated but may carry the risk of dehydration and hypoglycemia particularly during the long fasting hours. The study aimed to assess the efficacy and safety of the use of SGLT2i for the first-time during Ramadan fasting.\u003c/p\u003e \u003cp\u003e \u003cb\u003eMethods\u003c/b\u003e: This prospective cohort study was carried out on 61 Egyptian Muslim patients, aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years old, both sexes, with type 2 diabetes mellitus (T2DM), prepared to fast during Ramadan and treated with SGLT2i for the first time as a supplementary to metformin or another oral hypoglycemic drug. The dose of SGLT2i started after Iftar time. During and Six weeks after Ramadan, evaluations were conducted.\u003c/p\u003e \u003cp\u003e \u003cb\u003eResults\u003c/b\u003e: Glycated hemoglobin (HbA1c), blood pressure (systolic and diastolic), and creatinine were significantly lower after Ramadan than at the beginning of Ramadan. The estimated glomerular filtration rate (eGFR) was significantly higher after Ramadan than at the beginning of Ramadan. Hypoglycemia, dehydration, and diabetic ketoacidosis (DKA) did not occur in any patient. There was a significant negative correlation between age and HbA1c (r=-0.267, P\u0026thinsp;=\u0026thinsp;0.037) and eGFR (r =-0.684, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001) after Ramadan while there was no correlation between the duration of DM and HbA1c before and after Ramadan. HbA1c was significantly lower after Ramadan than during Ramadan in patients with ischemic heart disease (IHD), hypertension (HTN), peripheral neuropathy (PN), and chronic kidney disease (CKD) (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e \u003cp\u003e \u003cb\u003eConclusions\u003c/b\u003e: SGLT2i is effective and safe during Ramadan fasting with a significant reduction in HBA1c, blood pressure, and creatinine and a significant elevation of eGFR.\u003c/p\u003e \u003cp\u003eTrial registration Clinical Trials giv ID: NCT06370247\u003c/p\u003e","manuscriptTitle":"First-time Usage of SGLT2 Inhibitors in Patients with Type 2 Diabetes Who Are Fasting Ramadan: Efficacy and Safety","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-06 14:47:15","doi":"10.21203/rs.3.rs-4473992/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3b85e717-eca3-4e06-8068-f318f135b8f3","owner":[],"postedDate":"August 6th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":34512687,"name":"Health sciences/Medical research"},{"id":34512688,"name":"Health sciences/Endocrinology"}],"tags":[],"updatedAt":"2024-12-16T14:30:35+00:00","versionOfRecord":[],"versionCreatedAt":"2024-08-06 14:47:15","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4473992","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4473992","identity":"rs-4473992","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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