Puberty Suppression and Cardiometabolic Health

Recruiting

• Conditions: Transgenderism; Endothelial Dysfunction; Vascular Stiffness; Insulin Sensitivity/Resistance

• Registration Number: NCT04482374
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-22
• Study Start: 2020-08-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity	Baseline, 6 months	Insulin sensitivity assessed by the oral minimal model

Secondary Outcome Measures

Name	Time	Method
Change in body composition (fat mass, fat-free mass)	Baseline, 6 months	Body composition measured by DXA
Change in resting metabolic rate	Baseline, 6 months	Resting metabolic rate assessed by indirect calorimetry
Change in large elastic artery stiffness	Baseline, 6 months	Large elastic assessed by carotid ultrasound
Change in endothelial function	Baseline, 6 months	Endothelial function assessed by brachial artery flow mediated dilation
Change in cerebrovascular function	Baseline, 6 months	Middle cerebral artery blood flow assessed using bilateral transcranial Doppler

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States