Recruiting

Puberty Suppression

Sponsor:

University of Colorado, Denver

Code:

NCT04482374

Conditions

Transgenderism

Insulin Sensitivity/Resistance

Endothelial Dysfunction

Vascular Stiffness

Eligibility Criteria

Sex: Male

Age: 9 - 14

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Transgenderism

Insulin Sensitivity/Resistance

Endothelial Dysfunction

Vascular Stiffness

Study ID

NCT04482374

Start date

Aug 10, 2020

Status verified date

Jun, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 9 - 14

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Transgender females

Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months

Cisgender males

Cisgender male controls

Primary outcome measure

  • Change in insulin sensitivity [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Natalie J Nokoff, MD, MSCS

720-777-6128natalie.nokoff@childrenscolorado.org

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Natalie Nokoff, MD, MSCS

720-777-3607Natalie.Nokoff@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-06-10.