Clinical trial NCT06627504: Type 1 Diabetes REst for Metabolic Health
Official title: Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes (T1D)
Sleep Health
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 \&lt;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 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\&lt;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.

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: Baseline (following 1 month typical sleep) and following 1 month intervention
measure: Cardiovascular Function
timeFrame: Baseline (following 1 month typical sleep) and following 1 month intervention
measure: Glycemic Control
timeFrame: Baseline (following 1 month typical sleep) and following 1 month intervention
Secondary outcomes:
measure: Inflammation
timeFrame: Baseline (following 1 month typical sleep) and following 1 month intervention
measure: Adipokines
timeFrame: Baseline (following 1 month typical sleep) and following 1 month intervention
measure: Cortisol
timeFrame: Baseline (following 1 month typical sleep) and following 1 month intervention
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children&#39;s Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Stacey L Simon, PhD
role: PRINCIPAL_INVESTIGATOR
References: