RecruitingNCT06245681

Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content

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


Sponsor

Medical University of Vienna

Enrollment

40 participants

Start Date

Oct 20, 2017

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria2

  • DSM-IV diagnosis of Gender Identity Disorder
  • age over 18 years

Exclusion Criteria8

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGgender affirming hormone therapy

both groups are receiving gender-affirming hormone therapy; we do not compare the groups, but look at whether hormone therapy with testosterone or estrogen might have an effect on myocardial function, organ lipid content and subcutaneous to visceral fat ratio


Locations(1)

Chiari Stoffwechselambulanz, Medical University of Vienna

Vienna, Vienna, Austria

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06245681


Related Trials