Effects of hormone treatment on heart and liver health in transgender individuals
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
This study tests how hormone treatment affects heart and liver health in transgender individuals by looking at changes before and after six months of therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT06245681 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the impact of cross-sex hormone therapy on cardiovascular function and fat content in the liver and heart among transgender individuals. Participants will undergo two MRI scans, one before starting hormone treatment and another after six months of therapy, to assess changes in their cardiovascular health. Additionally, an oral glucose tolerance test will be conducted at both time points to evaluate metabolic changes. The study seeks to clarify the gender-specific cardiovascular changes associated with high-dose hormone therapy in male-to-female and female-to-male transgender individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are transgender individuals aged 18 and older who are diagnosed with Gender Identity Disorder and are about to begin hormone therapy.
Not a fit: Patients with severe neurological or internal diseases, those under 18 years old, or individuals currently on steroid hormone treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the cardiovascular risks associated with hormone therapy, leading to improved health management for transgender patients.
How similar studies have performed: While there is existing literature on the effects of sex hormones on cardiovascular health, this specific approach focusing on transgender individuals undergoing hormone therapy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * DSM-IV diagnosis of Gender Identity Disorder * age over 18 years Exclusion Criteria: * age under 18 years severe neurological or internal diseases * steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones) * treatment with psychotropic agents such as SSRIs * any implant or stainless-steel graft * abnormal values in routine laboratory screening or general physical examination * current substance abuse (determined using drug screening at the screening visit) * pregnancy (determined at screening visit and first MRI scan) * failure to comply with the study protocol or to follow the instructions of the investigating
Where this trial is running
Vienna, State of Vienna
- Chiari Stoffwechselambulanz, Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- 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.