Actively Recruiting
Long-term Observational Study of Gender-affirming Hormone Therapy Effects on Heart Function, Organ Fat, Insulin System, and Psychological Health
Led by Medical University of Vienna · Updated on 2025-09-26
50
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe the long-term effects of gender affirming hormone therapy (GAHT) on transgender men and women. The study focuses on how GAHT influences cardiovascular risk factors, insulin system function, body composition, metabolic measures, and psychological health after 2, 5, and 10 years of treatment. It seeks to fill gaps in knowledge about mid- to long-term impacts using advanced imaging and psychological assessments. Participants include transgender men and women who have received GAHT for the past 2 years and were part of a prior pilot study. Transgender women receive estrogen via gel or oral forms, sometimes with additional medications, while transgender men receive testosterone by injection or gel. The study does not alter hormone treatments but monitors patients at three time points: after 2, 5, and 10 years of therapy. During each visit, participants undergo magnetic resonance imaging and spectroscopy to measure heart, liver, and pancreatic fat, as well as cardiac function. They also complete blood tests including an oral glucose tolerance test, physical measurements, and fill out psychological questionnaires assessing mood and emotional control. This comprehensive monitoring helps researchers evaluate changes in heart health, metabolism, body fat distribution, and mental wellbeing over time.
CONDITIONS
Brief Title
Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participation in the pilot study
- Receiving gender affirming hormone therapy for the last 2 years
- Willingness and ability to sign informed consent
You will not qualify if you...
- Under 18 years of age
- Having implants, grafts, or tattoos not safe for MRI
- Claustrophobia
- Current substance abuse
- Pregnancy
- Not following study instructions or protocol compliance failure
- Any condition making participation unsafe or unsuitable as judged by study team or protocol rules
- Participation in other conflicting studies or treatments during the study period (implied by protocol compliance, if applicable)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 years (follow-up at 2, 5, and 10 years of therapy)
Participants who have been receiving gender affirming hormone therapy for 2 years are observed over time to evaluate effects on heart function, organ fat content, insulin system, and psychological health through MRI scans, blood tests, glucose tolerance tests, psychological assessments, and physical measurements.
3 visits (in-person) at 2, 5, and 10 years of treatment
Trial Site Locations
Total: 1 location
1
Chiari Stoffwechselambulanz, Medical University of Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
Research Team
C
Carola Deischinger, MD PHD
A
Alexandra Kautzky-Willer, Prof., MD
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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