Puberty Suppression and Cardiometabolic Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transgenderism, Insulin Sensitivity/Resistance, Endothelial Dysfunction, Vascular Stiffness. Basic parameters: 9 years — 14 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
Overview
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.
Primary outcome measures
- Change in insulin sensitivity [Time frame: Baseline, 6 months]
Secondary outcome measures (5)
- Change in body composition (fat mass, fat-free mass) [Time frame: Baseline, 6 months]
- Change in resting metabolic rate [Time frame: Baseline, 6 months]
- Change in endothelial function [Time frame: Baseline, 6 months]
- Change in large elastic artery stiffness [Time frame: Baseline, 6 months]
- Change in cerebrovascular function [Time frame: Baseline, 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Colorado Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT04482374 · 19-2109