Evaluating puberty suppression effects on health in transgender youth
Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 9 Years to 14 Years |
| Sex | Male |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04482374 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with cognitive, psychiatric, or physical impairments, diabetes, or those on medications affecting insulin sensitivity may not benefit from this study.
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 performed: While there is limited data on this specific approach, related studies on puberty suppression and metabolic health have shown promising results.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.