Study of Efficacy and Safety of Dapagliflozin on Metabolic Parameters in Patients of Type II Diabetes with Metabolic Dysfunction-Associated Steatotic Liver Disease

Background Metabolic dysfunction associated steatotic liver disease formerly called non alcoholic fatty liver disease is a common condition caused by accumulation of fat in the liver linked to obesity, insulin resistance and type 2 diabetes mellitus. It affects around thirty percent of the global population and nearly one fifth of adults in India. People with metabolic risk factors are more prone to develop this disease. The condition can progress to steatohepatitis, fibrosis and even liver cancer. Dapagliflozin, a sodium glucose cotransporter 2 inhibitor, has shown benefits beyond glucose control by reducing liver enzymes, body weight, triglycerides and improving insulin sensitivity. This suggests its potential role in managing metabolic dysfunction associated steatotic liver disease.

Purpose of the study The study aims to evaluate the efficacy and safety of dapagliflozin ten milligram once daily on metabolic parameters in patients with type two diabetes and metabolic dysfunction associated steatotic liver disease. It will assess its effect on blood glucose levels, lipid profile, body weight, body mass index, liver fibrosis markers such as FIB four, CAP and LSM, and overall liver function. Adverse effects and tolerability will also be monitored.

In summary, this is a phase four prospective open label single arm interventional study conducted at MGM Medical College and Hospital, Chhatrapati Sambhaji Nagar, to explore the metabolic and liver protective benefits of dapagliflozin in diabetic patients with metabolic dysfunction associated steatotic liver disease.