China Gender-affirming Hormone Therapy Study in Transgender Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change from Baseline Insulin Sensitivity at 12 months
研究概览
简要总结
Data about transgender medical care, especially the gender-affirming hormone therapy (GAHT) is extremely insufficient in China. Few evidence exists in the physical and psychological effects of the hormonal treatment in Chinese transgender population. CGAHT is designed to describe the social and mental condition of transgender people who are seeking for formal GAHT, and to investigate the physical and psychological effects of GAHT on this population in China.
详细描述
CGAHT will be conducted in one of the main transgender medical centers in Chinese mainland. Participants who are seeking for the start of GAHT will be enrolled from clinical visitors. Before GAHT, participants will be interviewed with questionaries about their life experience, gender identity and social economic conditions. Evaluations on mental and physical health will be performed at baseline and during the GAHT. Participants will be followed up to 12 months. GAHT will be given to transgender people according to the protocol recommended by the international guideline (doi: 10.1210/jc.2017-01658) .
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Transgender men and women
- •Meet criteria of Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) for gender dysphoria
- •Aged between 18 to 40 years
- •People desire to start the GAHT
- •No previous history of gender-affirming interventions
- •Having full ability to make informed consent
- •Dextromanual
排除标准
- •Disorders of sex development
- •Who has fertility demand but have not made fertility preservation
- •With contradictions of GAHT
- •Comorbid diseases are not under control
- •Alcohol or drug abuse
- •Hormonal and chromosomal disorders
- •History of gender affirming surgery
- •Current psychiatric disorders
- •History of brain trauma or neurological pathologies
- •Current use of medications with psychotropic effects within two weeks (antipsychotic or antiepileptic agents, lithium, benzodiazepines or opioid analgesics)
- •Claustrophobia
- •Implanted metal and medical devices (pacemakers, ceramic teeth, etc.),
- •Tattoos or eyebrow tattooing (heavy metal dye)
研究组 & 干预措施
transgender men
People whose sex assigned at birth is female but whose self-identified gender is male.
干预措施: GAHT for transgender men (Drug)
transgender women
People whose sex assigned at birth is male but whose self-identified gender is female.
干预措施: GAHT for transgender women (Drug)
结局指标
主要结局
Change from Baseline Insulin Sensitivity at 12 months
时间窗: 12 months
Insulin sensitivity will be assessed with composite insulin sensitivity index (ISI), which is calculated as 10 000/√\[(fasting glucose \[mg/dL\]) ×(fasting insulin \[μU/mL\]) × (mean glucose \[mg/dL\]) × (mean insulin \[μU/mL\])\], using 0 min, 60 min, and 120 min values of oral glucose tolerance test (OGTT). Composite ISI will be evaluated at baseline and every 6 months until 12 months of GAHT.
Anxiety Changes from Baseline Psychological Questionnaires at 12 months
时间窗: 12 months
Generalized anxiety disorder scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Functional brain Change after 6 months of GAHT
时间窗: 6 months
Change of functional connectivity will be analyzed to understand at 6 months of GAHT.
Change from Baseline Beta-cell Function at 12 months
时间窗: 12 months
Beta-cell function will be assessed with oral glucose tolerance test-derived disposition index (DI). First, 60 min insulinogenic index (IGI60) is calculated as (insulin60 min-insulin0 min\[μU/mL\])/(glucose60 min-glucose0 min \[mmol/L\]), using 0 min and 60 min values of OGTT. Then DI is calculated by multiplying IGI60 with composite ISI to reflect beta-cell function adjusting for the insulin sensitivity. DI will be evaluated at baseline and every 6 months until 12 months of GAHT.
Social Exclusion Changes from Baseline at 12 months
时间窗: 12 months
Cyberball task will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT.
Suicide Ideation Changes from Baseline Psychological Questionnaires at 12 months
时间窗: 12 months
Beck scale for suicide ideation will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Gender Dysphoria Changes from Baseline Psychological Questionnaires at 12 months
时间窗: 12 months
Utrecht gender dysphoria scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Change from Baseline Bone Mineral Density at 12 months
时间窗: 12 months
Bone mineral densities (g/cm\^2) of lumber spine and hip will be evaluated by dual-energy X-ray absorptiometry at baseline and 12 months of GAHT.
Depression Changes from Baseline Psychological Questionnaires at 12 months
时间窗: 12 months
Patient Health Questionnaire will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
次要结局
- Change from Baseline Waist-hip Ratio at 12 months(12 months)
- Comparison of Transgender and Cisgender Functional Brain Patterns(At baseline)
- Change from Baseline Body Mass Index at 12 months(12 months)
- Change from Baseline Breast Volume of transgender women at 12 months(12 months)
- Comparison of Transgender and Cisgender Cognitive Ability(At baseline)
- Incidence of Treatment-Emergent Adverse Events(Up to 12 months)
- Change from Baseline Body Composition at 12 months(12 months)
- Change from Baseline Homeostatic Model Assessment Index (HOMA-IR) at 12 months(12 months)
- Change from Baseline Homeostatic Model Assessment of Beta-cell function (HOMA-β) at 12 months(12 months)
- Change from Baseline Serum Uric Acid at 12 months(12 months)
研究者
Hong Tianpei
Professor
Peking University Third Hospital