An interventional study of Sleep manipulation in Sleep, sponsored by Children's Hospital of Eastern Ontario. Completed at 1 site in Canada. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Children's Hospital of Eastern Ontario · Not applicable, Interventional, and Prevention
BACKGROUND: The influence of sleep extension on glucose homeostasis in adolescents at risk for type 2 diabetes is unknown. This issue is of high clinical relevance given the high prevalence of sleep deprivation in this population and the accumulating body of evidence indicating that having a good night's sleep is important for the prevention of chronic diseases including type 2 diabetes.
OBJECTIVE: To determine if extending sleep duration improves insulin sensitivity in adolescents presenting with risk factors for type 2 diabetes.
HYPOTHESIS: It was hypothesized that compared with decreasing sleep duration, increasing sleep duration by 1.5 hours over 1 week will improve insulin sensitivity.
METHODS: Using a randomized, counterbalanced, 2-condition crossover design, 30 obese adolescents between 13 and 18 years of age who have insulin resistance will complete the study. Participants will sleep their typical amount at home for 1 week and will then be randomized to either increase or decrease their time in bed by 1.5 hours per night for 1 week, completing the alternate schedule on the fourth week (washout period of at least 1 week between sleep conditions). This procedure will result in a targeted 3-hour time in bed difference between conditions. Sleep will be objectively measured using actigraphy (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and wake times during the experimental weeks, and will be monitored through phone calls to the research center. Participants will also be compensated for keeping the sleep schedule and daily calls to enhance adherence. The outcome measures will then be compared between both sleep conditions at the end (on day 8 of each study week). The primary outcome measure will be insulin sensitivity as measured by the Matsuda index (total body insulin sensitivity). Secondary outcomes will include the homeostasis model assessment of insulin resistance (HOMA-IR), blood lipids, food intake and physical activity. Repeated measures analysis using the mixed model will be used to assess the effect of the two sleep interventions on insulin sensitivity.
RELEVANCE: The study will provide the first robust clinical evidence to determine if increasing sleep duration in youth at risk for type 2 diabetes improves insulin sensitivity. This information will be essential for clinical and public health guidelines for type 2 diabetes prevention among adolescents.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 35 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Children's Hospital of Eastern Ontario is the lead sponsor of 83 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Increase in time in bed of 1.5 hours per night for one week
Behavioral: Sleep manipulation
Decrease in time in bed of 1.5 hours per night for one week
Behavioral: Sleep manipulation
Participants will sleep their typical amount at home for 1 week and will then be randomized to either increase or decrease their time in bed by 1.5 hours per night for 1 week, completing the alternate schedule on the fourth week (washout period of 1 week between sleep conditions). This procedure will result in a targeted 3-hour time in bed difference between conditions. Sleep will be objectively measured using actigraphy (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and wake times during the experimental weeks, and will be monitored through phone calls to the research center.
Insulin sensitivity
Assessed by the Matsuda index during a 2-hour oral glucose tolerance test (OGTT)
Time frame: On day 8 of each sleep condition (2 time points)
Insulin sensitivity
HOMA-IR
Time frame: On day 8 of each sleep condition (2 time points)
Blood lipids
HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol
Time frame: On day 8 of each sleep condition (2 time points)
Food intake
3-day dietary record
Time frame: On days 5, 6 and 7 of each sleep condition (2 time points)
Physical activity level
Minutes per day of moderate-to-vigorous physical activity as assessed by accelerometry
Time frame: During each 7-day sleep condition (2 time points)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Eastern Ontario