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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

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Conditions

TransgenderismInsulin Sensitivity/ResistanceEndothelial DysfunctionVascular Stiffness

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States