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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02550431
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
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.

Condition or disease
Transgendered Persons

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 Design
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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth
Actual Study Start Date : March 2016
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: LGBTQIA+ Health

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Data on quality of life as measured by the Pediatric Quality of Life Inventory (PedsQL) compared to published norms [ Time Frame: at enrollment ]

Biospecimen Retention:   Samples Without DNA
Blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550431


Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Natalie J Nokoff, MD University of Colorado, Denver
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02550431    
Other Study ID Numbers: 15-1215
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018