Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Location status: Recruiting
NCT Number: NCT06627504
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).
Interested in participating?
Request Info14 year–19 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Value of central aortic stiffness from cardiovascular MRI
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Value of mean sensor glucose assessed with continuous glucose monitor
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Laboratory values of hs-CRP, IL-6, and TNF-alpha
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Laboratory values of leptin and adiponectin
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Laboratory values of cortisol
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes
Acronym: T1DREaM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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