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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03754036
Other study ID # 17/63X
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2019
Est. completion date December 12, 2021

Study information

Verified date July 2022
Source Children's Hospital of Eastern Ontario
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 12, 2021
Est. primary completion date December 12, 2021
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria: - Adolescents between the ages of 13 and 18 with obesity (body mass index greater than the 95th percentile) and dyslipidemia (total cholesterol = 200 mg/dL; low-density lipoprotein cholesterol = 130 mg/dL; non-high-density lipoprotein = 145 mg/dL; triglycerides = 130 mg/dL; and high-density lipoprotein < 40 mg/dL) - Adolescents who report between 6.5-8 hours of sleep per night will be eligible to ensure that adolescents can extend and restrict sleep duration without reaching a ceiling for what can be achieved (i.e. 8-10 hours/night of sleep is recommended at this age) while limiting excessive sleep deprivation Exclusion Criteria: - History of a chronic medical or psychiatric condition - Use of medications that could affect sleep or glucose homeostasis (e.g., metformin, thyroid medication, stimulant medication, etc.) - History of sleep problems (e.g. sleep apnea).

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Children's Hospital of Eastern Ontario Research Institute Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insulin sensitivity Assessed by the Matsuda index during a 2-hour oral glucose tolerance test (OGTT) On day 8 of each sleep condition (2 time points)
Secondary Insulin sensitivity HOMA-IR On day 8 of each sleep condition (2 time points)
Secondary Blood lipids HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol On day 8 of each sleep condition (2 time points)
Secondary Food intake 3-day dietary record On days 5, 6 and 7 of each sleep condition (2 time points)
Secondary Physical activity level Minutes per day of moderate-to-vigorous physical activity as assessed by accelerometry During each 7-day sleep condition (2 time points)
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