Puberty Suppression and Cardiometabolic Health

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482374
• Other study ID #: 19-2109
• Status: Recruiting
• Start date: August 10, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Natalie J Nokoff, MD, MSCS
• Phone: 720-777-6128
• Email: natalie.nokoff[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Gender: Male
• Age group: 9 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity/Resistance
• Transgenderism
• Vascular Stiffness

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity	Insulin sensitivity assessed by the oral minimal model	Baseline, 6 months
Secondary	Change in body composition (fat mass, fat-free mass)	Body composition measured by DXA	Baseline, 6 months
Secondary	Change in resting metabolic rate	Resting metabolic rate assessed by indirect calorimetry	Baseline, 6 months
Secondary	Change in endothelial function	Endothelial function assessed by brachial artery flow mediated dilation	Baseline, 6 months
Secondary	Change in large elastic artery stiffness	Large elastic assessed by carotid ultrasound	Baseline, 6 months
Secondary	Change in cerebrovascular function	Middle cerebral artery blood flow assessed using bilateral transcranial Doppler	Baseline, 6 months