NCT06245681 Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content
| NCT ID | NCT06245681 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Gender Dysphoria |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2017-10-20 |
| Primary Completion | 2027-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2017-10-20 with a primary completion date of 2027-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06245681 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Gender Dysphoria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06245681 currently recruiting?
Yes, NCT06245681 is actively recruiting participants. Contact the research team at carola.deischinger@meduniwien.ac.at for enrollment information.
Where is the NCT06245681 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06245681 clinical trial?
NCT06245681 is sponsored by Medical University of Vienna. The trial plans to enroll 40 participants.