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.

China Gender-affirming Hormone Therapy Study

Transgender

Gender Incongruence

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) .

GAHT for transgender men

GAHT for transgender women

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

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.

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.

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.

Patient Health Questionnaire will be tested at baseline and every 3 months until 12
months to understand the effects of GAHT

Generalized anxiety disorder scale will be tested at baseline and every 3 months until 12
months to understand the effects of GAHT

Beck scale for suicide ideation will be tested at baseline and every 3 months until 12
months to understand the effects of GAHT

Utrecht gender dysphoria scale will be tested at baseline and every 3 months until 12
months to understand the effects of GAHT

Cyberball task will be tested at baseline and every 3 months until 12 months to
understand the effects of GAHT.

Change of functional connectivity will be analyzed to understand at 6 months of GAHT.

Professor

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.

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.

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.

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.

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.

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.

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.

Serum Uric Acid levels (μmol/l) will be evaluated at baseline and every 3 months until 12
months of GAHT.

Functional connectivity will be compared at baseline to understand the brain patterns of
transgender.

Performance of mental rotation task of transgender and cisgender will be compared at
baseline to understand the difference.

People whose sex assigned at birth is female but whose self-identified gender is male.

People whose sex assigned at birth is male but whose self-identified gender is female.

People whose sex assigned at birth corresponds with their self-identified gender.

China Gender-affirming Hormone Therapy Study

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status