Clinical trial NCT02550431: Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth
Official title: Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transgendered Persons
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 58
Sex: ALL
Minimum age (years): 9
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: at enrollment
measure: 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
timeFrame: at enrollment
measure: Body composition as measured by Dual-energy X-ray absorptiometry (DEXA) in transgender youth compared to age- and BMI-matched controls of both sexes.
timeFrame: at enrollment
measure: Data on quality of life as measured by the Pediatric Quality of Life Inventory (PedsQL) compared to published norms
timeFrame: at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Natalie J Nokoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nokoff NJ, Scarbro SL, Moreau KL, Zeitler P, Nadeau KJ, Reirden D, Juarez-Colunga E, Kelsey MM. Body Composition and Markers of Cardiometabolic Health in Transgender Youth on Gonadotropin-Releasing Hormone Agonists. Transgend Health. 2021 Apr 16;6(2):111-119. doi: 10.1089/trgh.2020.0029. eCollection 2021 Apr.
citation: Nokoff NJ, Scarbro SL, Moreau KL, Zeitler P, Nadeau KJ, Juarez-Colunga E, Kelsey MM. Body Composition and Markers of Cardiometabolic Health in Transgender Youth Compared With Cisgender Youth. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e704-14. doi: 10.1210/clinem/dgz029.