China Gender-affirming Hormone Therapy Study

Recruiting

• Conditions: Transgender; Gender Incongruence
• Interventions: Drug: GAHT for transgender men; Drug: GAHT for transgender women

• Registration Number: NCT05318755
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-08
• Study Start: 2022-04-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
transgender men	GAHT for transgender men	People whose sex assigned at birth is female but whose self-identified gender is male.
transgender women	GAHT for transgender women	People whose sex assigned at birth is male but whose self-identified gender is female.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Insulin Sensitivity at 12 months	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	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	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	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	12 months	Cyberball task will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT.
Depression Changes from Baseline Psychological Questionnaires at 12 months	12 months	Patient Health Questionnaire 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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Waist-hip Ratio at 12 months	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.
Comparison of Transgender and Cisgender Functional Brain Patterns	At baseline	Functional connectivity will be compared at baseline to understand the brain patterns of transgender.
Change from Baseline Body Mass Index at 12 months	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.
Change from Baseline Breast Volume of transgender women at 12 months	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.
Comparison of Transgender and Cisgender Cognitive Ability	At baseline	Performance of mental rotation task of transgender and cisgender will be compared at baseline to understand the difference.
Incidence of Treatment-Emergent Adverse Events	Up to 12 months	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.
Change from Baseline Body Composition at 12 months	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.
Change from Baseline Homeostatic Model Assessment Index (HOMA-IR) at 12 months	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.
Change from Baseline Homeostatic Model Assessment of Beta-cell function (HOMA-β) at 12 months	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.
Change from Baseline Serum Uric Acid at 12 months	12 months	Serum Uric Acid levels (μmol/l) will be evaluated at baseline and every 3 months until 12 months of GAHT.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Peking, Beijing, China