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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Transgenderism

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: marianne andersen, Professor; Phone Number: +4565412502; Email: msa@rsyd.dk
• Study Contact Backup: Name: Louise Christensen, MD; Phone Number: +4565412502; Email: louise.lehmann.christensen@rsyd.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Mariannne S Andersen, Prof; Phone Number: +4565412502; Email: msa@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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. -

Description

Inclusion Criteria:

Transgender men

Exclusion Criteria:

none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
transgender men; no intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Marianne Andersen
• Investigators: Principal Investigator: Marianne Andersen, Odense University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Anticipated): January 1, 2044
• Study Completion (Anticipated): January 1, 2044

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BICTX01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No