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Sleep Extension and Insulin Sensitivity in Adolescents

Primary Purpose

Sleep

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleep manipulation
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Children's Hospital of Eastern Ontario Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleep Extension

Sleep Restriction

Arm Description

Increase in time in bed of 1.5 hours per night for one week

Decrease in time in bed of 1.5 hours per night for one week

Outcomes

Primary Outcome Measures

Insulin sensitivity
Assessed by the Matsuda index during a 2-hour oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Insulin sensitivity
HOMA-IR
Blood lipids
HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol
Food intake
3-day dietary record
Physical activity level
Minutes per day of moderate-to-vigorous physical activity as assessed by accelerometry

Full Information

First Posted
November 23, 2018
Last Updated
July 18, 2022
Sponsor
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT03754036
Brief Title
Sleep Extension and Insulin Sensitivity in Adolescents
Official Title
Effect of Increasing Sleep Duration on Insulin Sensitivity in Adolescents Having Risk Factors for Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2019 (Actual)
Primary Completion Date
December 12, 2021 (Actual)
Study Completion Date
December 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Sleep restriction (-1.5 hours of sleep per day for 1 week) and Sleep extension (+1.5 hours of sleep per day for 1 week)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Extension
Arm Type
Experimental
Arm Description
Increase in time in bed of 1.5 hours per night for one week
Arm Title
Sleep Restriction
Arm Type
Experimental
Arm Description
Decrease in time in bed of 1.5 hours per night for one week
Intervention Type
Behavioral
Intervention Name(s)
Sleep manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
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)
Secondary Outcome Measure Information:
Title
Insulin sensitivity
Description
HOMA-IR
Time Frame
On day 8 of each sleep condition (2 time points)
Title
Blood lipids
Description
HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol
Time Frame
On day 8 of each sleep condition (2 time points)
Title
Food intake
Description
3-day dietary record
Time Frame
On days 5, 6 and 7 of each sleep condition (2 time points)
Title
Physical activity level
Description
Minutes per day of moderate-to-vigorous physical activity as assessed by accelerometry
Time Frame
During each 7-day sleep condition (2 time points)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep Extension and Insulin Sensitivity in Adolescents

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