Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content

NCT06291675 | Recruiting

• 1 other identifier: 2083/2022
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Gender affirming hormone therapy (GAHT) leads to profound changes in sex hormone levels, carrying a wide range of implications for major physiological processes in the body. GAHT has been shown to be associated with changes in cardiovascular parameters, the insulin system, body composition, and the psychological state. However, despite the fact that GAHT is usually a long-term intervention, the majority of the research concerns itself with an overall short duration of the therapy and the data on the mid- to long-term effects of GAHT is scarce. Objectives: The study aims to investigate the effects of gender affirming hormone therapy on the cardiovascular risk profile, insulin system, body composition, various metabolic parameters, and the psychological state after 2, 5, and 10 years of the treatment. Study design: The study is designed as an observational longitudinal monocentric study, which includes transgender men and transgender women who have been taking gender affirming hormone therapy during the past 2 years and took part in our pilot study. Our probands will undergo a magnetic resonance scan, extensive bloodwork, an oral glucose tolerance test, and a psychological self-assessment after 2, 5, and 10 years of the treatment. Materials and methods: The magnetic resonance imaging and spectroscopy will be performed with a 3-Tesla magnetic resonance device. We will also perform an extensive blood analysis and an 75g- 2h oral glucose tolerance test. Additionally, the psychological state of the probands will be assessed with 3 questionnaires. Study population: 30 transgender men 30 transgender women who participated in our pilot study and have been taking the gender affirming hormone therapy for the past 2 years. Relevance and implications of the study: The majority of previous research has focused on the short-term effects of gender affirming hormone therapy. Contrastingly, our study aims to focus on the effects of hormone therapy at 2, 5 and 10 years after the beginning of the treatment. Moreover, our study group utilizes measurements of myocardial, hepatic, and pancreatic fat content as well as an MR-assisted measurement of cardiac function, which is a topic that has not been present in research into the effects of gender affirming hormone therapy outside of our pilot study.

Conditions

Gender Dysphoria; Hormone Therapy Induced Morphologic Change

Outcome Measures

Primary Outcomes (5)

• Myocardial mass

  to examine the effects of gender affirming hormone treatment on myocardial mass (in g/m³)

  after 2, 5 and 10 years of gender-affirming hormone therapy

• Cardiac function - LVEF

  to examine the effects of gender affirming hormone treatment on left-ventricular ejection fraction (in %) (LVEF) using MR-assisted measurements

  after 2, 5 and 10 years of gender-affirming hormone therapy

• cardiac function - cardiac output index

  to examine the effects of gender affirming hormone treatment on cardiac output index (in L/min/m²) using MR-assisted measurements

  after 2, 5 and 10 years of gender-affirming hormone therapy

• Organ lipid content

  to examine the effects of gender affirming hormone treatment on hepatic, pancreatic, and myocardial fat content after 2, 5, and 10 years of the treatment using MR-assisted measurements

  after 2, 5 and 10 years of gender-affirming hormone therapy

• Subcutaneous to visceral fat ratio

  to examine the effects of gender affirming hormone treatment on subcutaneous to visceral fat ratio after 2, 5, and 10 years of the treatment using MR-assisted measurements

  after 2, 5 and 10 years of gender-affirming hormone therapy

Study Arms (2)

Transgender women

Transgender women included in this study receive estrogen, either transdermally (Estrogel-Gel®, Estradot® or Estramon®) or orally (Estrofem®). If needed, the treatment can be supplemented by cyproterone acetate (Androcur®), and/or an alpha-5-reductase inhibitor (Finasterid Actavis/Arcana/Aurobindo®). The GAHT of our probands is prescribed and managed independently of the study, and the study has no effect on the treatment.

Drug: gender-affirming hormone therapy

Transgender men

The cohort of transgender men are persons who receive testosterone either intramuscularly (Nebido®) or transdermally (Testogel® or Testavan®). The GAHT of our probands is prescribed and managed independently of the study, and the study has no effect on the treatment.

Drug: gender-affirming hormone therapy

Interventions

gender-affirming hormone therapy DRUG

We are not technically involved in the prescription of gender-affirming hormone therapy. We merely aim at observing effects of GAHT on MRI measured organ lipid content, myocardial mass and function.

Transgender men; Transgender women

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender men and transgender women are selected according to their experienced gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our study aims to enroll transgender probands who took part in our pilot study. 30 transgender women and 30 transgender men will be recruited from the pool of participants in the previous pilot study (EK 1629/2017). The study will include transgender participants between 18 and 99 years of age, who have been taking gender affirming hormone therapy for the past 2 years. The study will not include a placebo group or a control group, and it will not interfere with the gender affirming hormone therapy in any way regarding composition and time course of the treatment.

You may qualify if:

• participation in our pilot study
• ongoing gender affirming hormone therapy during the last 2 years
• willingness and competence to sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Chiari Stoffwechselambulanz, Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Alexandra Kautzky-Willer, Prof, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

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 25, 2024
• First Posted: March 4, 2024
• Study Start: March 3, 2023
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 3, 2033
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

AU (1)