Clinical trial NCT04254354: Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgenderism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons assigned female at birth (+18 years) that either use or want to use testosterone with the purpose of undergoing gender transformation. -

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.

Eligibility criteria: Inclusion Criteria:

Transgender men

Exclusion Criteria:

none

Primary outcomes:
measure: Effect of testosterone on devellopment of plaques in the heart
timeFrame: 10 years
Secondary outcomes:
measure: Calcium score
timeFrame: 10 years
measure: Change in muscle strength and power
timeFrame: 10 years
measure: Effect of transgender treatment on quality of life
timeFrame: 10 years
measure: Effect of transgender treatment on aggression
timeFrame: 10 years
measure: Changes in maximal oxygen consumption during transgender treatment
timeFrame: 10 years
measure: Heart function
timeFrame: 10 years
measure: Respiratory function
timeFrame: 10 years
measure: Levels of testosterone, estradiol and cortisol
timeFrame: 10 years
measure: circulating markers of inflammation
timeFrame: 10 years
measure: circulating markers of cardiovascular risk
timeFrame: 10 years
measure: Assessment of cortisol/cortisone
timeFrame: 10 years
measure: Change in lean body mass
timeFrame: 10 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Marianne Andersen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lehmann Christensen L, Glintborg D, Taulbjerg Kristensen T, Diederichsen A, T'Sjoen G, Frystyk J, Skovsager Andersen M. Masculinising testosterone treatment and effects on preclinical cardiovascular disease, muscle strength and power, aggression, physical fitness and respiratory function in transgender men: protocol for a 10-year, prospective, observational cohort study in Denmark at the Body Identity Clinic (BIC). BMJ Open. 2020 Dec 29;10(12):e045714. doi: 10.1136/bmjopen-2020-045714.