NCT04482374Recruiting
Puberty Suppression and Cardiometabolic Health
University of Colorado, Denver
Start Date
8/10/2020
Completion Date
7/31/2026
Summary
This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.
Eligibility Criteria
Age Range: 9 years to 14 years
Inclusion Criteria:
* Identify as a transgender female or cisgender male
* Age 9-14 years at the time of enrollment
* Tanner Stage 2-3 baseline pubertal development
* Plan to start gonadotropin releasing hormone analogue clinically in \< 2 months (for transgender females only)
Exclusion Criteria:
* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* Type 1 or 2 diabetes (by medical history)
* On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
* Hypertension (resting BP ≥ 140/90 mm/Hg)
* Weight \> 400 lbs
* On estrogen- or progesterone-containing medications at baseline
* \>3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit
Conditions
TransgenderismInsulin Sensitivity/ResistanceEndothelial DysfunctionVascular Stiffness
Locations
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States