Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC

Recruiting

• Conditions: Transgenderism

• Registration Number: NCT04254354
• Lead Sponsor: Marianne Andersen

Brief Summary

The aim of this study is to investigate transgender men and non-binary persons before and during testosterone treatment. The study will focus on:

* Cardiovascular status

* Muscle strenght and power

* Aggression and quality of life

* Cardiac and respiratory function

Detailed Description

Introduction: The number of individuals with gender dysphoria seeking gender-affirming treatment is increasing. The short- and long-term effects of masculinizing treatment with testosterone are debated as serum testosterone increase up to 20-fold compared to cisgender women. We hypothesize that, testosterone treatment is associated with non-calcified coronary plaque (NCP) development in transgender men.

Methods and analyses: Prospective, single-center, observational cohort study at the Body Identity Clinic (BIC), Odense University Hospital, Denmark, where all investigations are performed at inclusion and after 1, 3, 5 and 10 years of testosterone therapy.

Ethics and dissemination: The Regional Committees on Health Research Ethics for Southern Denmark (S-20190108) and the Danish Data Protection Agency approved the study (19/27572). Signed informed consent will be obtained from all participants. All findings will be published in peer-reviewed journals or at scientific conferences.

Study Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-02-02
• Study First Posted: 2020-02-05
• Study Start: 2020-03-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2044-01-01
• Study Completion: 2044-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Transgender men

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of testosterone on devellopment of plaques in the heart	10 years	Estimated directly by CCTA, at start, (1 year for early included participants) 5 and 10 years

Secondary Outcome Measures

Name	Time	Method
Heart function	10 years	Ejection fraction and left ventricular muscle mass are measured by echocardiography at start,(1 for early included participants) 5 and 10 years
Assessment of cortisol/cortisone	10 years	measured in urine and hair samples by LCMS/MS
Effect of transgender treatment on quality of life	10 years	Estimated by quality of life questionnaire (SF36) at start, 1, 3, 5 and 10 years
Levels of testosterone, estradiol and cortisol	10 years	Measured in serum by LCMS/MS
Change in muscle strength and power	10 years	Estimated by low row and accelometer at start, 1, 3, 5, 10 years
Effect of transgender treatment on aggression	10 years	Estimated by aggression questionnaire at start, 1, 3, 5 and 10 years
circulating markers of inflammation	10 years	CRP in blood samples
circulating markers of cardiovascular risk	10 years	Lipids, SuPAR in blood samples
Change in lean body mass	10 years	Estimated by dual x-ray absorptiometry at start, 1, 3, 5 and 10 years
Changes in maximal oxygen consumption during transgender treatment	10 years	Estimated by test og maximal oxygen consumption (vo2max) at start, 1, 3, 5 and 10 years
Respiratory function	10 years	Forced Expiratory Volume in the first second and forced vital capacity estimated by spirometry at start, 1, 3, 5 and 10 years
Calcium score	10 years	CCTA

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark