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.
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) .
Study Type
OBSERVATIONAL
Enrollment
240
Testosterone undecanoate
Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange from Baseline Insulin Sensitivity at 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.
Time frame: 12 months
Change from Baseline Beta-cell Function at 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.
Time frame: 12 months
Change from Baseline Bone Mineral Density at 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.
Time frame: 12 months
Depression Changes from Baseline Psychological Questionnaires at 12 months
Patient Health Questionnaire will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Time frame: 12 months
Anxiety Changes from Baseline Psychological Questionnaires at 12 months
Generalized anxiety disorder scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Time frame: 12 months
Suicide Ideation Changes from Baseline Psychological Questionnaires at 12 months
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Beck scale for suicide ideation will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Time frame: 12 months
Gender Dysphoria Changes from Baseline Psychological Questionnaires at 12 months
Utrecht gender dysphoria scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Time frame: 12 months
Social Exclusion Changes from Baseline at 12 months
Cyberball task will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT.
Time frame: 12 months
Functional brain Change after 6 months of GAHT
Change of functional connectivity will be analyzed to understand at 6 months of GAHT.
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events
The incidence of adverse events during the 12 months of GAHT will be calculated, including thromboembolic events, drug-induced liver injury, hyperkalemia, newly diagnosed cardiovascular disease, erythrocytosis and newly diagnosed tumor.
Time frame: Up to 12 months
Change from Baseline Body Mass Index at 12 months
Body mass index is calculated as \[weight (kg) / height (m)\^2\], which will be evaluated at baseline and every 3 months until 12 months of GAHT.
Time frame: 12 months
Change from Baseline Waist-hip Ratio at 12 months
Waist-hip ratio is calculated as \[waist (cm)/hip (cm)\], which will be evaluated at baseline and every 3 months until 12 months of GAHT.
Time frame: 12 months
Change from Baseline Body Composition at 12 months
Fat percentage (%) and lean mass (kg) will be assessed using the InBody S10. The body composition will be evaluated at baseline and 12 months of GAHT.
Time frame: 12 months
Change from Baseline Breast Volume of transgender women at 12 months
Breasts of transgender women will be shot in 360° with 3D photography. The volume (ml) of both sides will be measured by the image analysis at baseline and every 6 months until 12 months of GAHT.
Time frame: 12 months
Change from Baseline Homeostatic Model Assessment Index (HOMA-IR) at 12 months
HOMA-IR is calculated as \[(fasting insulin \[µU/mL\] × fasting glucose \[mmol/L\])/22.5\]. HOMA-IR will be evaluated at baseline and every 6 months until 12 months of GAHT.
Time frame: 12 months
Change from Baseline Homeostatic Model Assessment of Beta-cell function (HOMA-β) at 12 months
HOMA-β is calculated as \[20 × (fasting insulin \[μU/mL\]) × (fasting glucose -3·5 \[mmol/L\])\]. HOMA-β will be evaluated at baseline and every 6 months until 12 months of GAHT.
Time frame: 12 months
Change from Baseline Serum Uric Acid at 12 months
Serum Uric Acid levels (μmol/l) will be evaluated at baseline and every 3 months until 12 months of GAHT.
Time frame: 12 months
Comparison of Transgender and Cisgender Functional Brain Patterns
Functional connectivity will be compared at baseline to understand the brain patterns of transgender.
Time frame: At baseline
Comparison of Transgender and Cisgender Cognitive Ability
Performance of mental rotation task of transgender and cisgender will be compared at baseline to understand the difference.
Time frame: At baseline