Puberty Suppression and Cardiometabolic Health

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04482374

Collaborator

(none)

Enrollment

Location

30.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transgenderism Insulin Sensitivity/Resistance Endothelial Dysfunction Vascular Stiffness

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 10, 2020

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Transgender females Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months
Cisgender males Cisgender male controls

Outcome Measures

Primary Outcome Measures

Change in insulin sensitivity [Baseline, 6 months]
Insulin sensitivity assessed by the oral minimal model

Secondary Outcome Measures

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 endothelial function [Baseline, 6 months]
Endothelial function assessed by brachial artery flow mediated dilation
Change in large elastic artery stiffness [Baseline, 6 months]
Large elastic assessed by carotid ultrasound
Change in cerebrovascular function [Baseline, 6 months]
Middle cerebral artery blood flow assessed using bilateral transcranial Doppler

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 14 Years

Sexes Eligible for Study:

Male

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT04482374

Other Study ID Numbers:

19-2109

First Posted:

Jul 22, 2020

Last Update Posted:

Oct 27, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Insulin Resistance

Hypersensitivity

Study Results

No Results Posted as of Oct 27, 2021