Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Purpose
To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.
Conditions
- Transgenderism
- Gender Dysphoria
- Insulin Sensitivity
Eligibility
- Eligible Ages
- Between 13 Years and 16 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
(transgender females): - Identify as a transgender female - Age 13-16 years at the time of enrollment - If on a gonadotropin releasing hormone analogue, > 6 months exposure - Plan to start estradiol clinically in < 4 months Inclusion Criteria (cisgender males and females): - Males and females ages 13-16 years
Exclusion Criteria
- Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures - Antipsychotic medication use - Type 1 or 2 diabetes (by medical history) - Polycystic ovarian syndrome (PCOS for cisgender females) - Hypertension (resting BP ≥ 140/90 mm/Hg) - Weight> 400 lbs - On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant) - Pregnancy (for cisgender females)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Transgender | ||
| Cisgender |
Recruiting Locations
Children's Hospital Colorado
Aurora, Colorado 80045
Aurora, Colorado 80045
More Details
- NCT ID
- NCT04596592
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver