Actively Recruiting

Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT06245681

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

Led by Medical University of Vienna · Updated on 2025-10-03

40

Participants Needed

1

Research Sites

574 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Gender Identity Disorder according to DSM-IV
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Severe neurological or internal diseases
  • Steroid hormone treatment within 2 months before joining (including birth control pill, phytohormones)
  • Use of psychotropic agents such as SSRIs
  • Any implant or stainless-steel graft
  • Abnormal results in routine lab tests or physical exam
  • Current substance abuse detected by drug screening
  • Pregnancy detected at screening or first MRI
  • Failure to follow study protocol or instructions

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chiari Stoffwechselambulanz, Medical University of Vienna

Vienna, State of Vienna, Austria, 1090

Actively Recruiting

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Research Team

C

Carola Deischinger, MD PhD

CONTACT

A

Alexandra Kautzky-Willer, Prof., MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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