Lehmann Christensen Louise, Glintborg Dorte, Taulbjerg Kristensen Tine, Diederichsen Axel, T'Sjoen Guy, Frystyk Jan, Skovsager Andersen Marianne
Body Identity Clinic, Department of Endocrinology, Odense University Hospital, Odense, Denmark
Odense University Hospital Department of Endocrinology, Odense, Denmark.
BMJ Open. 2020 Dec 29;10(12):e045714. doi: 10.1136/bmjopen-2020-045714.
The number of individuals with gender dysphoria seeking gender-affirming treatment is increasing. The short-term and long-term effects of masculinising treatment with testosterone are debated as serum testosterone increases up to 20-fold compared with cisgender women. We will investigate short-term and long-term effects of masculinising testosterone treatment on preclinical and clinical coronary disease, muscle strength and power, oxygen consumption (VO) max, cardiac and respiratory function and quality of life including aggression in transgender men.
Prospective, single-centre, observational cohort study at the Body Identity Clinic (BIC), Odense University Hospital, Denmark. Investigations are performed at inclusion and following 1, 3, 5 and 10 years of testosterone therapy. Non-calcified coronary plaque volume and calcium score are estimated by coronary CT angiography. CT is only performed at inclusion and following 1 and 10 years. Upper body muscle strength and power are measured by a 'low row' weight stack resisted exercise machine. Evaluation of aggression and quality of life is assessed by questionnaires, VO max is estimated by maximal testing on bike ergometer, and cardiac and respiratory functions are measured by echocardiography and spirometry, respectively. Markers of cardiovascular risk and inflammation and also cortisol and cortisone are assessed in blood, diurnal urine and/or hair samples. Our cohort (BIC), including dropouts, will be an embedded subcohort in a future national registry study in all individuals with gender dysphoria and controls. Data are available on International Statistical Classification of Diseases and Related Health Problems 10 version diagnostic codes, prescriptions, socioeconomics and causes of death.
The Regional Committee on Health Research Ethics for Southern Denmark (S-20190108) and the Danish Data Protection Agency (19/27572) approved the study. Signed informed consent will be obtained from all participants. All findings will be published in peer-reviewed journals or at scientific conferences.
NCT04254354.
寻求性别肯定治疗的性别焦虑症患者数量正在增加。由于血清睾酮水平与顺性别女性相比增加了20倍，睾酮男性化治疗的短期和长期影响存在争议。我们将研究睾酮男性化治疗对临床前和临床冠状动脉疾病、肌肉力量和功率、耗氧量（VO）最大值、心脏和呼吸功能以及生活质量（包括变性男性的攻击性）的短期和长期影响。
在丹麦欧登塞大学医院身体认同诊所（BIC）进行前瞻性、单中心观察性队列研究。在纳入研究时以及睾酮治疗1、3、5和10年后进行调查。通过冠状动脉CT血管造影估计非钙化冠状动脉斑块体积和钙化评分。CT仅在纳入研究时以及1年和10年后进行。通过“低划船”配重式阻力运动器械测量上身肌肉力量和功率。通过问卷评估攻击性和生活质量，通过自行车测力计最大测试估计VO最大值，分别通过超声心动图和肺活量测定法测量心脏和呼吸功能。在血液、日间尿液和/或毛发样本中评估心血管风险和炎症标志物以及皮质醇和可的松。我们的队列（BIC），包括失访者，将成为未来一项针对所有性别焦虑症患者和对照组的全国登记研究中的一个嵌入式子队列。可获得国际疾病分类及相关健康问题统计分类第10版诊断代码、处方、社会经济学和死亡原因的数据。
丹麦南部卫生研究伦理区域委员会（S-20190108）和丹麦数据保护局（19/27572）批准了该研究。将从所有参与者处获得签署的知情同意书。所有研究结果将发表在同行评审期刊或科学会议上。
NCT04254354。
