Puberty Suppression and Cardiometabolic Health
Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 22, 2020
CompletedStudy Start
First participant enrolled
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
June 10, 2025
June 1, 2025
6 years
June 30, 2020
June 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in insulin sensitivity
Insulin sensitivity assessed by the oral minimal model
Baseline, 6 months
Secondary Outcomes (5)
Change in body composition (fat mass, fat-free mass)
Baseline, 6 months
Change in resting metabolic rate
Baseline, 6 months
Change in endothelial function
Baseline, 6 months
Change in large elastic artery stiffness
Baseline, 6 months
Change in cerebrovascular function
Baseline, 6 months
Study Arms (2)
Transgender females
Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months
Cisgender males
Cisgender male controls
Eligibility Criteria
15 transgender females (male sex assigned at birth, female gender identity) and 15 cisgender males
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natalie J Nokoff, MD, MSCS
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 22, 2020
Study Start
August 10, 2020
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
June 10, 2025
Record last verified: 2025-06