Puberty Suppression and Cardiometabolic Health

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

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Natalie J Nokoff, MD, MSCS; Phone Number: 720-777-6128; Email: Natalie.Nokoff@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

15 transgender females (male sex assigned at birth, female gender identity) and 15 cisgender males

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Transgender females; Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months
Cisgender males; Cisgender male controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in insulin sensitivity	Insulin sensitivity assessed by the oral minimal model	Baseline, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Natalie J Nokoff, MD, MSCS, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Hyperinsulinism; Hypersensitivity; Insulin Resistance
• Other Study ID Numbers: 19-2109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No