Actively Recruiting
Led by Medical University of Vienna · Updated on 2025-10-03
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are studying the effects of high-dose cross-sex hormone therapy on heart and liver fat content, heart function, and insulin system changes in transgender individuals. The study focuses on understanding gender-specific cardiovascular changes in male-to-female and female-to-male transgender persons, aiming to clarify the role of sex hormones in atherosclerosis and cardiovascular risk factors. This pilot study is longitudinal and observational, involving 40 transgender participants aged 18 to 50, free of hormone medication at baseline. Participants receive clinically prescribed gender-affirming hormone therapy with either testosterone or estrogen. They will undergo two 3 Tesla MRI scan sessions, one before starting hormone therapy and one after six months of treatment, to assess myocardial and hepatic fat content and cardiac function. Additionally, an oral glucose tolerance test (OGTT) will be performed at baseline and after six months to measure changes in insulin sensitivity and secretion. The study does not include a placebo group and does not influence hormone therapy decisions. Throughout the 12-month study duration, participants will have detailed assessments including MRI scans of the heart and liver, sonography measurements, and blood tests for cholesterol, triglycerides, liver enzymes, inflammatory markers, and cardiovascular risk markers. Researchers will analyze changes in heart function, fat content, and insulin-related measures before and after hormone therapy. Participants can withdraw at any time, and the study follows ethical guidelines to ensure safety and compliance.
CONDITIONS
Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline assessments including magnetic resonance spectroscopy (MRS) of the heart and liver, sonography measurements, oral glucose tolerance tests (OGTT), and blood sampling before starting hormone therapy.
1 visit (in-person)
Duration - 6 months
Participants receive high-dose cross-sex hormone therapy prescribed by their doctors, with ongoing hormone treatment lasting at least 6 months.
Participants receive hormone therapy as part of their clinical care; no additional study visits during this period.
Duration - 1 day
Participants undergo follow-up assessments including repeated MRS, sonography, OGTT, and blood sampling to evaluate the effects of hormone therapy on cardiac function, lipid content, and insulin sensitivity.
1 visit (in-person)
Total: 1 location
1
Chiari Stoffwechselambulanz, Medical University of Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
C
Carola Deischinger, MD PhD
A
Alexandra Kautzky-Willer, Prof., MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Carola Deischinger, Dorota Slukova, Lana Kosi-Trebotic...
https://pubmed.ncbi.nlm.nih.gov/40153614