One-Year Study of Testosterone Undecanoate Versus Placebo on Liver Fat in Overweight or Obese Men With Type 2 Diabetes or Prediabetes and Low Testosterone, Followed by Two-Year Open Phase on Heart and Metabolic Health

What this Trial Is About

Researchers are investigating the impact of testosterone undecanoate compared to a placebo on reducing liver fat in overweight or obese men who have type 2 diabetes or prediabetes along with low testosterone hypogonadism. This condition may contribute to metabolic syndrome, cardiovascular disease, and non-alcoholic fatty liver disease NAFLD, which are increasing worldwide and linked to insulin resistance and fat buildup in the liver. The study also explores the role of testosterone in glucose metabolism and heart health in this high-risk group. Participants receive either intramuscular injections of testosterone undecanoate 1000mg4ml at the start, after 6 weeks, and then every 10 weeks for a total of 52 weeks, or a similar placebo injection on the same schedule. After this 52-week randomized, quadruple-blind phase, an additional open-label extension lasting 108 weeks will follow to examine long-term effects on cardiometabolic health. The study measures changes in liver fat, visceral fat, pancreatic fat, myocardial fat, glycemic control, and cardiovascular safety. During the study, participants undergo regular assessments including body measurements, blood tests for insulin sensitivity, HbA1c, lipid levels, blood pressure, and questionnaires on quality of life, sexual function, and diabetes management satisfaction. Imaging scans evaluate fat content in various organs and heart perfusion. Safety is closely monitored throughout both study phases. Total participation may last up to three years, combining the initial treatment and the extension period.

Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism