Sleep and IR in Transgender Adolescents

NCT05489159 | Completed

• 1 other identifier: Pro00110732
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Disordered sleep is a health issue with significant impacts on physical and psychological well-being that has increased in prevalence, but its impact on transgender adolescents has not been fully quantified. While there is found to be an impact of sex steroids on sleep, and sex-dependent differences in the impact of sleep duration and quality on insulin resistance (IR), there is limited available information regarding the impact of Gender Affirming Hormone Therapy (GAHT) for transgender individuals on sleep and IR. Our study aims to quantify the impacts of GAHT on sleep and IR in the pediatric transgender population as well as determine the degree of correlation of sleep to IR in this population.

Conditions

Sleep Disorder; Insulin Resistance; Gender Dysphoria

Keywords

Disordered sleep; Insulin Resistance; Gender Dysphoria; Metabolomics; Actigraphy

Outcome Measures

Primary Outcomes (4)

• Change in Sleep Duration as measured by actigraphy device.

  An actigraphy device will track sleep and assay facets of sleep quality

  baseline, 12 months

• Change in Subjective Sleep Quality as measured by sleep questionnaires

  1. The PROMIS Pediatric Sleep Disturbances and Sleep Practices questionnaires will be aggregated to derive sleep quality 2. The PROMIS sleep questionnaires are paired with self-report and parent proxy set of measures where a child's sleep disturbances/practices are rated on a scale of Never to Always and sleep schedules are indicated.

  baseline, 12 months

• Change in Objective Sleep Quality as measured by actigraphy device

  An actigraphy device will track sleep and assay facets of sleep quality

  baseline, 12 months

• Change in Insulin Resistance as measured by aggregation of lab results

  HOMA-IR and surrogate measures of (a) metabolomic signatures related to insulin resistance, (b) serum adiponectin, and (c) triglyceride:HDL ratio will be aggregated to determine overall risk of insulin resistance

  baseline, 12 months

Eligibility Criteria

• Age: 12 Years - 18 Years
• Gender Eligibility Details: Identify as transgender or non-binary and plan to undergo treatment with gender-affirming hormone therapy (GAHT).
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects for this study will be recruited from the Duke Child and Adolescent Gender Care Clinic, and we will follow transmasculine and transfeminine adolescents as they initiate GAHT.'Transmasculine' will refer to patients who were assigned female at birth, identified as male or non-binary, and who will undergo masculinizing GAHT 'Transfeminine' will refer to patients who were assigned male at birth, identify as female or non-binary, and who will undergo feminizing GAHT.

You may qualify if:

• to 18 (inclusive) years of age,
• Identify as transgender or non-binary and plan to undergo treatment with GAHT.

You may not qualify if:

• Prior treatment with GAHT or puberty-blockers (GnRH agonists),
• Known Diabetes Mellitus,
• Current or recent (within the past month) use of systemic corticosteroids, medications for weight loss or topiramate,
• Proteinuria or chronic kidney disease, which could affect the metabolomic profiling

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Insulin Resistance; Gender Dysphoria

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Sexual Dysfunctions, Psychological

Study Design

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

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 5, 2022
• Study Start: October 12, 2022
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: January 16, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)