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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL174735 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Health and Circadian Timing Intervention | Experimental | 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. |
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| Typical Sleep | No Intervention | Participants will be asked to sleep on their usual schedule. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Health and Circadian Timing Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | 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 | Baseline (following 1 month typical sleep) and following 1 month intervention |
| Cardiovascular Function | Value of central aortic stiffness from cardiovascular MRI | Baseline (following 1 month typical sleep) and following 1 month intervention |
| Glycemic Control | Value of mean sensor glucose assessed with continuous glucose monitor | Baseline (following 1 month typical sleep) and following 1 month intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | Laboratory values of hs-CRP, IL-6, and TNF-alpha | Baseline (following 1 month typical sleep) and following 1 month intervention |
| Adipokines | Laboratory values of leptin and adiponectin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angel Bernard, BS | Contact | 720-777-3491 | angel.bernard@childrenscolorado.org |
| Name | Affiliation | Role |
|---|---|---|
| Stacey L Simon, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
All fully deidentified raw and processed/scored data will be shared.
Access to the data will be made at the end of the grant award or when a publication has been submitted. Once the data are submitted, the archive will control the long-term persistence of the data set.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline (following 1 month typical sleep) and following 1 month intervention |
| Cortisol | Laboratory values of cortisol | Baseline (following 1 month typical sleep) and following 1 month intervention |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |