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Puberty Suppression and Cardiometabolic Health

Description

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.

Conditions

TransgenderismInsulin Sensitivity/ResistanceEndothelial DysfunctionVascular Stiffness
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Related Conditions:

TransgenderismInsulin Sensitivity/ResistanceEndothelial DysfunctionVascular Stiffness

Study Overview

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Study Details

Study overview

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.

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

Puberty Suppression and Cardiometabolic Health

Condition
Transgenderism
Intervention / Treatment

-

Contacts and Locations

Aurora

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

9 Years to 14 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Natalie J Nokoff, MD, MSCS, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

2025-07-31