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

NCT06245681 | Recruiting

• 1 other identifier: 1629/2017
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Dysphoria

Outcome Measures

Primary Outcomes (6)

• Hepatic lipid content

  changes in the hepatic lipid content (in percent) due to long-term gender-affirming hormone therapy therapy measured by MRT

  6 months

• Pancreatic lipid content

  changes in pancreatic lipid content (in percent) due to long-term gender-affirming hormone therapy therapy measured by MRT

  6 months

• Myocardial lipid content

  changes in myocardial lipid content (in percent) due to long-term gender-affirming hormone therapy therapy measured by MRT

  6 months

• Cardiac function

  the effect of the hormone therapy on heart function (systolic and diastolic)

  6 months

• Changes in insulin sensitivity via OGTT

  changes in insulin sensitivity via OGTT

  6 months

• changes in insulin secretion via OGTT

  changes in insulin secretion via OGTT

  6 months

Study Arms (2)

Transgender women

Transgender individuals assigned male at birth undergoing estrogen and antiandrogen hormone therapy

Drug: gender affirming hormone therapy

Transgender men

Transgender individuals assigned female at birth undergoing testosterone hormone therapy

Drug: gender affirming hormone therapy

Interventions

gender affirming hormone therapy DRUG

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

Transgender men; Transgender women

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: We included individuals solely based on gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy transgender persons undergoing gender-affirming hormone therapy (either testosterone or estrogen-based hormone therapy

You may qualify if:

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

You may not qualify if:

• age under 18 years severe neurological or internal diseases
• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Chiari Stoffwechselambulanz, Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• Deischinger C, Slukova D, Kosi-Trebotic L, Harreiter J, Nopp S, Just I, Klepochova R, Krssak M, Trattnig S, Kaufmann U, Kautzky-Willer A. Gender-affirming hormone therapy and its impact on myocardial mass and cardiac function: a prospective magnetic resonance cohort study on transgender men and women. Eur J Endocrinol. 2025 Mar 27;192(4):429-436. doi: 10.1093/ejendo/lvaf057.

  PMID: 40153614 DERIVED

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Carola Deischinger, MD PhD

CONTACT

+43140400; carola.deischinger@meduniwien.ac.at

Alexandra Kautzky-Willer, Prof., MD

CONTACT

+43140400; alexandra.kautzky-willer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: October 20, 2017
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): October 20, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

AU (1)