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RECRUITING
NCT06245681

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

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

Summary

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.

Official title: Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content, Its (Anti)-Atherogenic Implications and Effects on the Insulin System: a Pilot Study

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2017-10-20

Completion Date

2028-10-20

Last Updated

2025-10-03

Healthy Volunteers

Yes

Interventions

DRUG

gender affirming hormone therapy

both 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

Locations (1)

Chiari Stoffwechselambulanz, Medical University of Vienna

Vienna, Vienna, Austria