Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Angel Bernard, BS
angel.bernard@childrenscolorado.org
720-777-3491
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 50
Treatments
Experimental: 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.
No_intervention: Typical Sleep
Participants will be asked to sleep on their usual schedule.
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov