Type 1 Diabetes REst for Metabolic Health

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes (T1D); Sleep Health
• Interventions: Behavioral: Sleep Health and Circadian Timing Intervention

• Registration Number: NCT06627504
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited. Therefore, this study plans to investigate whether cardiometabolic health can be improved with increased sleep duration and advanced circadian timing in adolescents with T1D with habitually insufficient sleep. To answer this question, investigators will study adolescents with T1D who get \<7h sleep on school nights and measure changes in insulin sensitivity, glycemic control, and vascular function after one month of a sleep and circadian intervention (1+ hour longer time in bed each night plus evening melatonin and morning light therapy) compared to one month of typical sleep (usual school schedule).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Study Start: 2024-12-01
• Primary Completion: 2029-05-31
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• High school students between the ages of 14-19 years;
• Diagnosed with T1D for ≥1 year;
• Using an insulin pump or other automated insulin delivery system;
• Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);
• With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
• Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.

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Exclusion Criteria

• Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep Disorders Inventory for Students-Adolescents measure
• Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);
• Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
• HbA1c ≥12%;
• Severe illness or DKA within 60 days;
• IQ<70 or severe mental illness impacting sleep or ability to participate in the study;
• Night-shift employment or other obligations that would preclude adherence to the intervention.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sleep Health and Circadian Timing Intervention	Sleep Health and Circadian Timing Intervention	Participants will be prescribed a sleep schedule that allows them to obtain at least 1h more time in bed compared to their typical school week schedule. In addition, participants will be provided with pharmaceutical-grade exogenous melatonin and instructed to take 500mcg 2 hours before their scheduled bedtime. They will also be asked reduce evening light exposure starting 2 hours before bedtime by limiting household lights and dimming electronics. In the mornings, participants will be exposed to bright light for 30 minutes after waking by wearing provided ReTimer light therapy glasses.

Primary Outcome Measures

Name	Time	Method
Insulin Sensitivity	Baseline (following 1 month typical sleep) and following 1 month intervention	Steady-state glucose infusion rate (M) normalized to free fat mass (FFM) and to steady-state insulin (M/I, \[mg/kg FFM/min\]/insulin) measured with hyperinsulinemic euglycemic clamp
Cardiovascular Function	Baseline (following 1 month typical sleep) and following 1 month intervention	Value of central aortic stiffness from cardiovascular MRI
Glycemic Control	Baseline (following 1 month typical sleep) and following 1 month intervention	Value of mean sensor glucose assessed with continuous glucose monitor

Secondary Outcome Measures

Name	Time	Method
Inflammation	Baseline (following 1 month typical sleep) and following 1 month intervention	Laboratory values of hs-CRP, IL-6, and TNF-alpha
Adipokines	Baseline (following 1 month typical sleep) and following 1 month intervention	Laboratory values of leptin and adiponectin
Cortisol	Baseline (following 1 month typical sleep) and following 1 month intervention	Laboratory values of cortisol

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States