Puberty Suppression and Cardiometabolic Health

Recruiting now

Conditions studied: Transgenderism, Insulin Sensitivity/Resistance, Endothelial Dysfunction, Vascular Stiffness

In brief

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.

Key facts

Study ID

NCT04482374

Run by

University of Colorado, Denver

People needed

30

Starts

2020-08-10

Expected to finish

2026-07-31

Last updated by the study team

2025-06-10

Who can join

Age: 9 and older, up to 14. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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