NCT04482374 Puberty Suppression and Cardiometabolic Health
| NCT ID | NCT04482374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Transgenderism |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-08-10 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2020-08-10 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Natalie J Nokoff, MD, MSCS
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT04482374 clinical trial?
This trial is open to male participants only, aged 9 Years or older, up to 14 Years, studying Transgenderism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04482374 currently recruiting?
Yes, NCT04482374 is actively recruiting participants. Contact the research team at natalie.nokoff@childrenscolorado.org for enrollment information.
Where is the NCT04482374 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT04482374 clinical trial?
NCT04482374 is sponsored by University of Colorado, Denver. The principal investigator is Natalie J Nokoff, MD, MSCS at University of Colorado, Denver. The trial plans to enroll 30 participants.