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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Effect of testosterone on devellopment of plaques in the heart
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Transgender men
排除标准
- 未提供
结局指标
主要结局
Effect of testosterone on devellopment of plaques in the heart
时间窗: 10 years
Estimated directly by CCTA, at start, (1 year for early included participants) 5 and 10 years
次要结局
- Heart function(10 years)
- Assessment of cortisol/cortisone(10 years)
- Effect of transgender treatment on quality of life(10 years)
- Levels of testosterone, estradiol and cortisol(10 years)
- Change in muscle strength and power(10 years)
- Effect of transgender treatment on aggression(10 years)
- circulating markers of inflammation(10 years)
- circulating markers of cardiovascular risk(10 years)
- Change in lean body mass(10 years)
- Changes in maximal oxygen consumption during transgender treatment(10 years)
- Respiratory function(10 years)
- Calcium score(10 years)
研究者
Marianne Andersen
Professor
Odense University Hospital