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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMedical University of Vienna

About this trial

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

This trial accepts healthy volunteers

Qualifiers

DSM-IV diagnosis of Gender Identity Disorder

age over 18 years

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Transgender women1 intervention
Group B: Transgender men1 intervention

Trial outcomes

Primary outcomes

1

Hepatic lipid content

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

Time frame
6 months
2

Pancreatic lipid content

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

Time frame
6 months
3

Myocardial lipid content

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

Time frame
6 months
4

Cardiac function

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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