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

Insulin Sensitivity/Resistance Endothelial Dysfunction Vascular Stiffness Transgenderism

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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