An Open Label Randomized Controlled Trial to evaluate the effect of Dapagliflozin on Cardiac autonomic functions in T2DM patients

Background: Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and impaired glucose regulation. Individuals with T2DM are at an increased risk of developing cardiovascular complications, including autonomic dysfunction, which affects the regulation of heart rate and blood pressure. SGLT2 inhibitors, such as Dapagliflozin, have emerged as a promising class of medications for managing T2DM by promoting glycosuria and improving glycemic control. Additionally, there is evidence suggesting that SGLT2 inhibitors may have beneficial effects on cardiovascular outcomes beyond glycemic control, including improvements in cardiac autonomic function.

Rationale: The rationale behind conducting an open-label randomized controlled trial to evaluate the effect of Dapagliflozin on cardiac autonomic functions in T2DM patients is multifaceted. Firstly, understanding the influence of SGLT2 inhibitors on cardiac autonomic function could provide valuable insights into their cardiovascular benefits beyond glycemic control. Secondly, elucidating the effects of Dapagliflozin on cardiac autonomic function may contribute to optimizing the management of T2DM and reducing the burden of cardiovascular complications in this patient population. Thirdly, cardiac autonomic dysfunction is a significant predictor of adverse cardiovascular events and mortality in T2DM patients, making it a clinically relevant endpoint to assess the efficacy of Dapagliflozin. Overall, this trial aims to address the gap in knowledge regarding the potential cardioprotective effects of SGLT2 inhibitors by evaluating their impact on cardiac autonomic function in individuals with T2DM.