China Gender-affirming Hormone Therapy Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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) .

Official Title
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China Gender-affirming Hormone Therapy Study in Transgender Men and Women

Conditions
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Transgender, Gender Incongruence

Intervention / Treatment
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* Drug: GAHT for transgender men
* Drug: GAHT for transgender women


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transgender men<br>People whose sex assigned at birth is female but whose self-identified gender is male. | Drug: GAHT for transgender men<br>* Testosterone undecanoate<br>* Other names: Testosterone;|
| transgender women<br>People whose sex assigned at birth is male but whose self-identified gender is female. | Drug: GAHT for transgender women<br>* Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)<br>* Other names: Feminizing drugs;|
| Healthy cisgender people<br>People whose sex assigned at birth corresponds with their self-identified gender. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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. | 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. | 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. | 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 | 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 | 12 months | 
| Suicide Ideation Changes from Baseline Psychological Questionnaires at 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 | 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 | 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. | 12 months | 
| Functional brain Change after 6 months of GAHT | Change of functional connectivity will be analyzed to understand at 6 months of GAHT. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 months | 
| Comparison of Transgender and Cisgender Functional Brain Patterns | Functional connectivity will be compared at baseline to understand the brain patterns of transgender. | 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. | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transgender Persons, Gender-affirming Hormone Therapy