RECRUITING

Puberty Suppression and Cardiometabolic Health

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Conditions

TransgenderismInsulin Sensitivity/ResistanceEndothelial DysfunctionVascular Stiffness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-08-10
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04482374

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.

Ages Eligible for Study:9 Years to 14 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Identify as a transgender female or cisgender male
  2. * Age 9-14 years at the time of enrollment
  3. * Tanner Stage 2-3 baseline pubertal development
  4. * Plan to start gonadotropin releasing hormone analogue clinically in \< 2 months (for transgender females only)
  1. * Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
  2. * Type 1 or 2 diabetes (by medical history)
  3. * On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
  4. * Hypertension (resting BP ≥ 140/90 mm/Hg)
  5. * Weight \> 400 lbs
  6. * On estrogen- or progesterone-containing medications at baseline
  7. * \>3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit

Contacts and Locations

Study Contact

Natalie J Nokoff, MD, MSCS
CONTACT
720-777-6128
natalie.nokoff@childrenscolorado.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-10
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2020-08-10
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

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