Actively Recruiting
Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
Led by University of Colorado, Denver · Updated on 2025-06-10
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how puberty suppression affects insulin sensitivity, metabolic rate, and vascular health in transgender female youth compared to cisgender male controls. This observational study focuses on youth aged 9 to 14 years who are in early stages of puberty (Tanner Stage 2-3). The goal is to understand changes in these health measures before and six months after starting treatment with a gonadotropin releasing hormone agonist. The study includes two groups: transgender females planning to begin puberty suppression treatment within two months, and matched cisgender male controls. Researchers will observe and compare changes in insulin sensitivity, body composition, resting metabolic rate, endothelial function, arterial stiffness, and cerebrovascular function at the start and six months after treatment initiation. Participants will undergo health assessments at baseline and six months later, including measures of insulin sensitivity, body fat and muscle mass, metabolic rate, and vascular health. The study monitors changes over time to understand the effects of puberty suppression. The total duration of participation is approximately six months, during which researchers will collect data to evaluate the treatment's impact on cardiometabolic health.
CONDITIONS
Brief Title
Puberty Suppression and Cardiometabolic Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 65 140/90 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants are observed to assess insulin sensitivity, metabolic rate, and vascular health over time.
2 visits (baseline and 6 months)
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
N
Natalie J Nokoff, MD, MSCS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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