Effect of Testosterone Therapy on Indices of MASLD in Men With Type 2 Diabetes Mellitus Having Low Testosterone Levels.

The study is a randomised open label parallel group single centre trial. Selection of study subjects will be done according to the inclusion and exclusion criteria. Total Sample size is 60 which will be divided into two groups; One group (n=30) will receive Inj Testosterone Undecanoate 1000mg deep I.M. at 0, 6 weeks, 3 months, 6 months and 9 months on top of standard diabetes and NAFLD care. Second group (n=30) will receive only standard diabetes and NAFLD care. Both the groups will receive dietary intervention and lifestyle modification by a trained dietician/ diabetes educator. The patients will be followed up at intervals of 3 months, 6 months and 9 months. The primary outcome is to study the change in CAP score at Baseline and at 9 months. (CAP- Controlled Attenuation Parameter, A modality of fibroscan to estimate hepatic steatosis) and secondary outcome is to study the change in non invasive indices of hepatic steatosis (Hepatic Steatosis Index [HSI], Fatty Liver Index [FLI], Triglyceride to HDL-C ratio [THR])  and fibrosis (AST to Platelet Ratio Index [APRI], Fibrosis-4 Index [FIB-4], NAFLD Fibrosis Score[NFS]) at baseline, 3 months, 6 months and 9 months and compare between the two groups.