Long-term Study on Sex Hormones and Cardiovascular Risk in Transgender Adults Using Gut Microbiome Analysis

What this Trial Is About

This research aims to understand how sex hormones affect the gut microbiome and the development of cardiovascular risk factors in healthy transgender individuals. The study will follow 200 participants over five years while they undergo hormone replacement therapy HRT. By using advanced scientific methods like omics platforms and detailed cardiovascular disease phenotyping, the study seeks to explore the role of circulating sex hormones in predicting cardiovascular risk markers. Participants will be observed during their hormone replacement therapy without receiving any study drug or intervention. Data collection will include analysis of the gut microbiome, metabolome, immunome, and cardiovascular health markers over multiple time points, including baseline, 2 years, 5 years, and optional 1-year follow-up visits. The study will also assess changes in hormone levels, immune markers, physical and mental health, lifestyle factors, and body composition. Participants will undergo evaluations at baseline and regularly throughout the follow-up period, including up to 60 months. Assessments include questionnaires on mental health, quality of life, diet, and physical activity, as well as measurements of vital signs and body composition. Researchers will track changes in bacterial species, cardiovascular markers, hormone levels, immune cells, and more. The study aims to provide a comprehensive view of how hormone therapy influences cardiovascular risk and the gut microbiome over time.

Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach