Study of Testosterone and Estrogen Effects on Eating, Metabolism, Energy, and Heart Health in Transsexual Patients Receiving Cross-Sex Hormone Therapy

What this Trial Is About

Researchers are studying the effects of cross-sex hormone therapy on several interconnected body systems in people undergoing this treatment for gender dysphoria. The study focuses on glucose and lipid metabolism, energy balance, eating behavior, functional brain networks related to eating, and the cardiovascular system. It also explores how the gut and oral microbiomes and metabolomes relate to these systems to better understand risks of overeating, obesity, insulin resistance, and heart disease. This observational study compares individuals starting cross-sex hormone therapy with a control group not receiving hormone treatment. Patients receive testosterone or estradiolantiandrogens according to medical guidelines, and no invasive procedures are performed. Measurements are taken before starting therapy and at several time points over five years, including assessments at 3, 6, 12, 24, and 60 months. Controls matched by age, BMI, and health status are included for comparison. Participants undergo detailed evaluations including physical exams, blood tests, body composition analysis, energy expenditure measurement, ultrasound of vessels, food intake tests, taste and smell assessments, and microbiome sample collection. Data on hormone levels, metabolism, cardiovascular health, and eating behavior are collected repeatedly. Safety monitoring includes non-invasive procedures and questionnaires. The study aims to follow participants for up to five years to understand long-term effects of hormone therapy on these physiological systems.

Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System