Actively Recruiting

Age: 9Years - 14Years
MALE
NCT04482374

Puberty Suppression and Cardiometabolic Health

Led by University of Colorado, Denver · Updated on 2025-06-10

30

Participants Needed

1

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Puberty Suppression and Cardiometabolic Health

Who Can Participate

Age: 9Years - 14Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Identify as a transgender female or cisgender male
  • Age 9 to 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)
Not Eligible

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 64; 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

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Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

N

Natalie J Nokoff, MD, MSCS

CONTACT

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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