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PUBERTY: Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT04596592
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
90
Enrollment
1
Location
53.5
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
    Actual Study Start Date :
    Feb 15, 2021
    Anticipated Primary Completion Date :
    Jul 31, 2025
    Anticipated Study Completion Date :
    Jul 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Transgender
    Cisgender

    Outcome Measures

    Primary Outcome Measures

    1. Insulin sensitivity [Change from baseline to 12 months]

    2. Brachial artery flow mediated dilation [Change from baseline to 12 months]

    Secondary Outcome Measures

    1. Large artery stiffness [Change from baseline to 12 months]

      Carotid artery ultrasound

    2. Cerebrovascular function [Change from baseline to 12 months]

      Middle cerebral artery blood flow

    3. VO2 peak [Change from baseline to 12 months]

    4. Fat mass [Change from baseline to 12 months]

      DXA

    5. Fat-free mass [Change from baseline to 12 months]

      DXA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 16 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria (transgender females):

    • Identify as a transgender female

    • Age 13-16 years at the time of enrollment

    • If on a gonadotropin releasing hormone analogue, > 6 months exposure

    • Plan to start estradiol clinically in < 4 months

    Inclusion Criteria (cisgender males and females):
    • Males and females ages 13-16 years
    Exclusion Criteria:

    • Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures

    • Antipsychotic medication use

    • Type 1 or 2 diabetes (by medical history)

    • Polycystic ovarian syndrome (PCOS for cisgender females)

    • Hypertension (resting BP ≥ 140/90 mm/Hg)

    • Weight> 400 lbs

    • On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)

    • Pregnancy (for cisgender females)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Colorado Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Natalie Nokoff, MD, MSCS, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT04596592
    Other Study ID Numbers:
    • 19-1226
    • 1K23HL151868-01
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Insulin Resistance
    Gender Dysphoria

    Study Results

    No Results Posted as of Apr 25, 2022