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

Condition(s) studied

Investigational drug(s) / intervention(s)

gender-affirming hormone therapy: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Myocardial mass — after 2, 5 and 10 years of gender-affirming hormone therapy
  to examine the effects of gender affirming hormone treatment on myocardial mass (in g/m³)
• Cardiac function - LVEF — after 2, 5 and 10 years of gender-affirming hormone therapy
  to examine the effects of gender affirming hormone treatment on left-ventricular ejection fraction (in %) (LVEF) using MR-assisted measurements
• cardiac function - cardiac output index — after 2, 5 and 10 years of gender-affirming hormone therapy
  to examine the effects of gender affirming hormone treatment on cardiac output index (in L/min/m²) using MR-assisted measurements
• Organ lipid content — after 2, 5 and 10 years of gender-affirming hormone therapy
  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
• Subcutaneous to visceral fat ratio — after 2, 5 and 10 years of gender-affirming hormone therapy
  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

Trial sites (1)

More Medical University of Vienna trials in Austria

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