A prospective observational case-controlled pilot study protocol on natural killer cell activity in patients with type 2 diabetes mellitus taking empagliflozin

Abstract Belonging to the innate immune system, natural killer (NK) cells play crucial roles in various kinds of cancers and other pathologies. The function and development of NK cells are regulated and enhanced by various inflammatory cytokines like common-γ chain family cytokines, transforming growth factor-β, interleukin (IL)-3, IL-10, IL-12, and IL-18. It has been found that their activity, as measured by interferon gamma assay release method, is decreased in Type 2 diabetes mellitus (T2DM) as well as prediabetes and is directly related to the degree of glycemic control. The multiple mechanisms shown by sodium-glucose cotransporter inhibitors (SGLT2Is) to address glycemic as well as non-glycemic inflammatory pathways make them an ideal candidate in most of our obese patients with T2DM since most of them are at higher cardiovascular (CV) risk. Obesity, a common comorbidity in T2DM, is also a known contributor of decreased NK cell activity. Since SGLT2Is have an indirect anti-inflammatory property, hence this study is intended to investigate any change in the NKC activity after initiating empagliflozin over 4 weeks in a cohort of well-controlled diabetic population.