About this trial
Background: Sex hormones are believed to play an important role in the development and progression of cardiovascular disease. However, the gender gap in onset and mortality is not yet completely understood. Transsexuals undergoing hormone therapy are a promising collective for analyzing the effects of sex hormones on atherosclerosis and other cardiovascular disease. Objectives of the study: To identify gender-specific cardiovascular changes attributed to high-dose hormone therapy in male-to-female (MtF) and female-to-male(FtM) transgender using sonography and magnet resonance spectroscopy. Study design: Longitudinal cohort study. Transsexuals will undergo two 3 Tesla MRI scan sessions: 1. baseline (before hormone treatment) and 2. after 6 months of treatment. An oral glucose tolerance test (OGTT) will be performed at baseline and 6 months after treatment onset. An overall study duration of 12 months is proposed.
Materials and Methods: MRI measurements will be performed on a 3 Tesla scanner. Study population: 10 FtM, 10 male-to-female MtF transsexuals (aged 18-50), free of hormone-medication at baseline. Relevance and implications of the study: Changes in atherosclerotic risk due to hormone therapy have been studied to no definite results and so far, little is known about the effects of hormone therapy on hepatic and myocardial fatty tissue. Hence this study will provide important new data on the broad clinical aspects of sex hormones as hormone replacement therapy in particularly opposite-sex hormone therapy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
DSM-IV diagnosis of Gender Identity Disorder
age over 18 years
Disqualifiers
age under 18 years severe neurological or internal diseases
steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones)
treatment with psychotropic agents such as SSRIs
any implant or stainless-steel graft
Trial population
healthy transgender persons undergoing gender-affirming hormone therapy (either testosterone or estrogen-based hormone therapy
Trial design
Cohort
Prospective
Treatments tested in this trial
gender affirming hormone therapy
Drugboth groups are receiving gender-affirming hormone therapy; we do not compare the groups, but look at whether hormone therapy with testosterone or estrogen might have an effect on myocardial function, organ lipid content and subcutaneous to visceral fat ratio
Treatment groups
Trial outcomes
Primary outcomes
Hepatic lipid content
changes in the hepatic lipid content (in percent) due to long-term gender-affirming hormone therapy therapy measured by MRT
Pancreatic lipid content
changes in pancreatic lipid content (in percent) due to long-term gender-affirming hormone therapy therapy measured by MRT
Myocardial lipid content
changes in myocardial lipid content (in percent) due to long-term gender-affirming hormone therapy therapy measured by MRT
Cardiac function
the effect of the hormone therapy on heart function (systolic and diastolic)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.