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Clinical Trials/NCT04482374
NCT04482374RecruitingNot Applicable

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

University of Colorado, Denver1 site in 1 country30 target enrollmentStarted: August 10, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Change in insulin sensitivity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
9 Years to 14 Years (Child)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in insulin sensitivity

Time Frame: Baseline, 6 months

Insulin sensitivity assessed by the oral minimal model

Secondary Outcomes

  • Change in body composition (fat mass, fat-free mass)(Baseline, 6 months)
  • Change in resting metabolic rate(Baseline, 6 months)
  • Change in large elastic artery stiffness(Baseline, 6 months)
  • Change in endothelial function(Baseline, 6 months)
  • Change in cerebrovascular function(Baseline, 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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