Pubertal Blockade and Hormone Therapy in Transgender Youth

NCT03557268 | Completed

• 1 other identifier: 17-2328
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll female-to-male transgender youth who are and are not on a puberty blocker (gonadotropin-releasing hormone analogue) at baseline and 1 and 12 months after starting testosterone. The study will evaluate markers of cardiometabolic health including: insulin sensitivity, laboratory markers, vascular health, body composition, activity/fitness, mitochondrial function and the microbiome.

Conditions

Gender Identity; Gender Dysphoria; Gender Identity Disorder in Adolescence and Adulthood

Outcome Measures

Primary Outcomes (2)

• Change in Insulin sensitivity

  Assessed by the Matsuda index, calculated from a 2-hour oral glucose tolerance test

  Baseline and 12 months after initiation of testosterone.

• Change in Vascular Health

  Brachial artery flow-mediated dilation

  Baseline and 12 months after initiation of testosterone.

Secondary Outcomes (3)

• Change in Mitochondrial function

  Baseline and 12 months after initiation of testosterone.

• Change in VO2 peak

  Baseline and 12 months after initiation of testosterone.

• Change in Body composition

  Baseline and 12 months after initiation of testosterone.

Study Arms (2)

On a GnRHa

Half of subjects will be on a puberty blocker or gonadotropin-releasing hormone analogue

Not on GnRHa

Half of subjects will NOT be on a puberty blocker or gonadotropin-releasing hormone analogue

Eligibility Criteria

• Age: 13 Years - 16 Years
• Gender Eligibility Details: Female-to-male transgender youth
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

16 female-to-male youth will be enrolled from 2 groups: 1) 8 female-to-male youth who have been on a gonadotropin-releasing hormone analogue for \> 6 months; 2) 8 female-to-male (age-matched) youth who never received gonadotropin-releasing hormone analogue therapy.

You may qualify if:

• Identify as female-to-male
• Age 13-16 years at the time of enrollment
• If on a gonadotropin-releasing hormone analogue, \> 6 months exposure
• Plan to start testosterone clinically in \< 6 months.

You may not qualify if:

• Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
• Diabetes
• Antipsychotic medication
• Hypertension (resting BP ≥ 140/90 mm/Hg)
• Weight \> 400 lbs (DXA and MRI limit)
• On estrogen and/or progesterone medications

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participants will have the options of banking plasma, serum, urine and stool for future research

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Natalie J Nokoff, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 14, 2018
• Study Start: June 19, 2018
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

US (1)