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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Masculinizing Testosterone Treatment and Effects on Preclinical Cardiovascular Disease, Muscle Strength and Power, Aggression, Physical Fitness and Respiratory Function in Transgender Men,Body Identity Clinic (BIC)

Conditions
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Transgenderism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Transgender men Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transgender men<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of testosterone on devellopment of plaques in the heart | Estimated directly by CCTA, at start, 1 year and 10 years | 10 years | 

Secondary Outcome Measures

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