Status:
RECRUITING
Puberty Suppression and Cardiometabolic Health
Lead Sponsor:
University of Colorado, Denver
Conditions:
Transgenderism
Insulin Sensitivity/Resistance
Eligibility:
MALE
9-14 years
Brief 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 initia...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04482374
Start Date
August 10 2020
End Date
July 31 2026
Last Update
June 10 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045