Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth

January 31, 2018 updated by: University of Colorado, Denver
This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

Study Overview

Status

Completed

Conditions

Detailed Description

This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

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.

Eligibility Criteria

Ages Eligible for Study

9 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Transgender youth ages 9 to 21 years of age who have been on a Gonadotropin-releasing hormone (GnRH) agonist or cross-sex hormones for at least three months

Description

Inclusion Criteria:

  • Followed in Endocrinology Clinic or Adolescent Medicine Clinic at Children's Hospital Colorado
  • Between age 9 and 21 years (inclusive)
  • Identifies as transgender
  • Has been on pubertal blockade or cross-sex hormones for at least three months.

Exclusion Criteria:

  • Known diabetes
  • Presence of significant medical or psychiatric comorbidities
  • Using hormones not prescribed by a physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reproductive hormone concentrations in transgender youth on cross-sex hormones and/or puberty blockers and compared to age-, natal sex- and body mass index (BMI)-matched controls.
Time Frame: at enrollment
at enrollment
Markers of cardiometabolic risk in transgender youth on cross-sex hormones and/or puberty blockers and compared to age-, natal sex- and BMI-matched controls
Time Frame: at enrollment
at enrollment
Body composition as measured by Dual-energy X-ray absorptiometry (DEXA) in transgender youth compared to age- and BMI-matched controls of both sexes.
Time Frame: at enrollment
at enrollment
Data on quality of life as measured by the Pediatric Quality of Life Inventory (PedsQL) compared to published norms
Time Frame: at enrollment
at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

January 26, 2018

Study Completion (Actual)

January 26, 2018

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 15-1215
  • UL1TR001082 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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