Type 1 Diabetes REst for Metabolic Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleep Health and Circadian Timing Intervention.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Sleep Health. Basic parameters: 14 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes
Overview
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).
Interventions
- Behavioral 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
Primary outcome measures
- Insulin Sensitivity [Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention]
- Cardiovascular Function [Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention]
- Glycemic Control [Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention]
Secondary outcome measures (3)
- Inflammation [Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention]
- Adipokines [Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention]
- Cortisol [Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Hospital Colorado — Aurora
Identifiers
NCT: NCT06627504 · 24-1490 · R01HL174735