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Observational Study on Puberty Suppression and Cardiometabolic Health

This observational study is looking at how puberty suppression affects the body's ability to use insulin (insulin sensitivity), how the body uses energy (metabolic rate), and the health of blood vessels (vascular health). It involves transgender female youth who are planning to start a gonadotropin releasing hormone analogue (a medication to suppress puberty) and compares them to cisgender male controls. The study will measure changes in insulin sensitivity at the beginning and again after 6 months. You can join if you are a transgender female or cisgender male between 9 and 14 years old, and are at a specific stage of puberty. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 30 participants. It compares transgender female youth to cisgender male controls.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting the gonadotropin releasing hormone analogue.

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NCT04482374

Puberty Suppression and Cardiometabolic Health

Recruiting
Not specifiedAges 9–14Observational
University of Colorado, Denver
~30 participants
Updated 2025-06-10 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in insulin sensitivity
Measured over Baseline, 6 months

Conditions

Transgenderism
Insulin Sensitivity/Resistance
Endothelial Dysfunction
Vascular Stiffness

Explore related trials

Endothelial dysfunctionInsulin SensitivityTransgenderismVascular Stiffness

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Natalie J Nokoff, MD, MSCS · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Natalie J Nokoff, MD, MSCS
[email protected]
720-777-6128
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in insulin sensitivityBaseline, 6 months

    Insulin sensitivity assessed by the oral minimal model