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NCT Number: NCT04482374

Puberty Suppression and Cardiometabolic Health

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.

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Key information

Conditions

Transgenderism Behavior Endothelial Dysfunction Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity/Resistance Metabolic Diseases Nutritional and Metabolic Diseases Sexual Behavior Sexuality Transsexualism Vascular Stiffness

Age range

9 year–14 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Natalie Nokoff, MD, MSCS

CONTACT

[email protected]

720-777-3607

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in insulin sensitivity

    Time frame: Baseline, 6 months

    Insulin sensitivity assessed by the oral minimal model

Secondary outcomes

  1. Change in body composition (fat mass, fat-free mass)

    Time frame: Baseline, 6 months

    Body composition measured by DXA

  2. Change in resting metabolic rate

    Time frame: Baseline, 6 months

    Resting metabolic rate assessed by indirect calorimetry

  3. Change in endothelial function

    Time frame: Baseline, 6 months

    Endothelial function assessed by brachial artery flow mediated dilation

  4. Change in large elastic artery stiffness

    Time frame: Baseline, 6 months

    Large elastic assessed by carotid ultrasound

  5. Change in cerebrovascular function

    Time frame: Baseline, 6 months

    Middle cerebral artery blood flow assessed using bilateral transcranial Doppler

Study contacts

Contact information is provided by the study sponsor or research team.

Natalie J Nokoff, MD, MSCS

CONTACT

[email protected]

720-777-6128

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2020
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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