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

This study is currently recruiting participants.
Verified October 2016 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT02550431
First Posted: September 15, 2015
Last Update Posted: October 27, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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
Transgendered Persons

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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

Estimated Enrollment: 100
Study Start Date: January 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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


Contacts
Contact: Natalie J Nokoff, MD 720-777-3607 Natalie.Nokoff@childrenscolorado.org

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Natalie Nokoff, MD    720-777-3607    Natalie.Nokoff@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Natalie J Nokoff, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02550431     History of Changes
Other Study ID Numbers: 15-1215
UL1TR001082 ( U.S. NIH Grant/Contract )
First Submitted: September 11, 2015
First Posted: September 15, 2015
Last Update Posted: October 27, 2016
Last Verified: October 2016