Effects of gender-affirming hormone therapy on heart and metabolic health
Long-term Observational Study to Investigate the Effect of Gender-affirming Hormone Therapy (GAHT) on Heart Function Parameters, Heart, Liver and Pancreatic Fat Content as Well as the Insulin System and the Psychological Impact of GAHT
This study is trying to see how gender-affirming hormone therapy affects heart health, metabolism, and mental well-being in transgender people over several years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT06291675 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the long-term effects of gender-affirming hormone therapy (GAHT) on cardiovascular health, insulin sensitivity, body composition, and psychological well-being in transgender individuals. Participants will be monitored over a period of 2, 5, and 10 years to assess changes in myocardial mass, cardiac function, and fat content in the heart, liver, and pancreas. The study aims to fill the gap in existing research regarding the mid- to long-term impacts of GAHT, which has been largely overlooked in previous studies.
Who should consider this trial
Good fit: Ideal candidates for this study are transgender men and women who have been undergoing gender-affirming hormone therapy for at least two years.
Not a fit: Patients under 18 years of age or those with non-MRI conditional implants, tattoos, or current substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term health implications of gender-affirming hormone therapy, potentially leading to improved care strategies for transgender individuals.
How similar studies have performed: While there is some existing research on the short-term effects of GAHT, this study's focus on long-term outcomes is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * participation in our pilot study * ongoing gender affirming hormone therapy during the last 2 years * willingness and competence to sign the informed consent form. Exclusion Criteria: * age \< 18 years * non-MRI conditional implants, grafts, and/or devices * non-MRI conditional tattoos * claustrophobia * current substance abuse * pregnancy * failure to comply with the study protocol and/or not following the instructions of the study team.
Where this trial is running
Vienna, State of Vienna
- Chiari Stoffwechselambulanz, Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Alexandra Kautzky-Willer, Prof, MD — Medical University of Vienna
- Study coordinator: Carola Deischinger, MD PHD
- Email: carola.deischinger@meduniwien.ac.at
- Phone: +43140400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.