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
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 Type
OBSERVATIONAL
Enrollment
200
Odense University Hospital
Odense, Denmark
RECRUITINGEffect of testosterone on devellopment of plaques in the heart
Estimated directly by CCTA, at start, (1 year for early included participants) 5 and 10 years
Time frame: 10 years
Calcium score
CCTA
Time frame: 10 years
Change in muscle strength and power
Estimated by low row and accelometer at start, 1, 3, 5, 10 years
Time frame: 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
Time frame: 10 years
Effect of transgender treatment on aggression
Estimated by aggression questionnaire at start, 1, 3, 5 and 10 years
Time frame: 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
Time frame: 10 years
Heart function
Ejection fraction and left ventricular muscle mass are measured by echocardiography at start,(1 for early included participants) 5 and 10 years
Time frame: 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
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Time frame: 10 years
Levels of testosterone, estradiol and cortisol
Measured in serum by LCMS/MS
Time frame: 10 years
circulating markers of inflammation
CRP in blood samples
Time frame: 10 years
circulating markers of cardiovascular risk
Lipids, SuPAR in blood samples
Time frame: 10 years
Assessment of cortisol/cortisone
measured in urine and hair samples by LCMS/MS
Time frame: 10 years
Change in lean body mass
Estimated by dual x-ray absorptiometry at start, 1, 3, 5 and 10 years
Time frame: 10 years