RecruitingNCT04482374
Puberty Suppression and Cardiometabolic Health
Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
Sponsor
University of Colorado, Denver
Enrollment
30 participants
Start Date
Aug 10, 2020
Study Type
OBSERVATIONAL
Conditions
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
Sex: MALEMin Age: 9 YearsMax Age: 14 Years
Inclusion Criteria4
- 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 Criteria7
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04482374
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