Evaluating puberty suppression effects on health in transgender youth
Official title: Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
Run by University of Colorado, Denver · NCT04482374 · Data updated 2026-11-12
This study is testing how puberty suppression affects health, like insulin sensitivity and heart health, in transgender girls compared to boys over six months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 9 Years to 14 Years |
| Sex | Men only |
| Enrollment | 30 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | August 10, 2020 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | June 10, 2025 |
| Trial ID | NCT04482374 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are transgender females aged 9-14 years who are at Tanner Stage 2-3 and plan to start gonadotropin-releasing hormone therapy within two months.
✕Probably not a fit
Patients with cognitive, psychiatric, or physical impairments, diabetes, or those on medications affecting insulin sensitivity may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study assesses how puberty suppression impacts insulin sensitivity, metabolic rate, and vascular health in transgender female youth. Participants will be evaluated at baseline and again six months after starting a gonadotropin-releasing hormone agonist. The study will also include matched cisgender male controls for comparison. The goal is to understand the cardiometabolic effects of puberty suppression in this population.
Why it matters
Potential benefit: If successful, this study could provide insights into the health impacts of puberty suppression on transgender youth, potentially guiding clinical practices.
How similar studies have gone: While there is limited data on this specific approach, related studies on puberty suppression and metabolic health have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Natalie J Nokoff, MD, MSCS — University of Colorado, Denver
- Study coordinator: Natalie J Nokoff, MD, MSCS
- Email: natalie.nokoff@childrenscolorado.org
- Phone: 720-777-6128
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.