Puberty Suppression and Cardiometabolic Health

NCT ID: NCT04482374

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-10

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Transgenderism Insulin Sensitivity/Resistance Endothelial Dysfunction Vascular Stiffness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transgender females

Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months

No interventions assigned to this group

Cisgender males

Cisgender male controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie J Nokoff, MD, MSCS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Natalie J Nokoff, MD, MSCS

Role: CONTACT

720-777-6128

Facility Contacts

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Natalie Nokoff, MD, MSCS

Role: primary

720-777-3607

Other Identifiers

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19-2109

Identifier Type: -

Identifier Source: org_study_id

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