Study of Cross-Sex Hormone Treatment Effects on Heart and Liver Fat, Cardiac Function, and Insulin System in Transgender Adults

What this Trial Is About

Researchers are studying the effects of high-dose cross-sex hormone therapy on heart and liver fat content, heart function, and insulin system changes in transgender individuals. The study focuses on understanding gender-specific cardiovascular changes in male-to-female and female-to-male transgender persons, aiming to clarify the role of sex hormones in atherosclerosis and cardiovascular risk factors. This pilot study is longitudinal and observational, involving 40 transgender participants aged 18 to 50, free of hormone medication at baseline. Participants receive clinically prescribed gender-affirming hormone therapy with either testosterone or estrogen. They will undergo two 3 Tesla MRI scan sessions, one before starting hormone therapy and one after six months of treatment, to assess myocardial and hepatic fat content and cardiac function. Additionally, an oral glucose tolerance test OGTT will be performed at baseline and after six months to measure changes in insulin sensitivity and secretion. The study does not include a placebo group and does not influence hormone therapy decisions. Throughout the 12-month study duration, participants will have detailed assessments including MRI scans of the heart and liver, sonography measurements, and blood tests for cholesterol, triglycerides, liver enzymes, inflammatory markers, and cardiovascular risk markers. Researchers will analyze changes in heart function, fat content, and insulin-related measures before and after hormone therapy. Participants can withdraw at any time, and the study follows ethical guidelines to ensure safety and compliance.

Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content