<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03754036</url>
  </required_header>
  <id_info>
    <org_study_id>17/63X</org_study_id>
    <nct_id>NCT03754036</nct_id>
  </id_info>
  <brief_title>Sleep Extension and Insulin Sensitivity in Adolescents</brief_title>
  <official_title>Effect of Increasing Sleep Duration on Insulin Sensitivity in Adolescents Having Risk Factors for Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Eastern Ontario</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Eastern Ontario</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: The influence of sleep extension on glucose homeostasis in adolescents at risk&#xD;
      for type 2 diabetes is unknown. This issue is of high clinical relevance given the high&#xD;
      prevalence of sleep deprivation in this population and the accumulating body of evidence&#xD;
      indicating that having a good night's sleep is important for the prevention of chronic&#xD;
      diseases including type 2 diabetes.&#xD;
&#xD;
      OBJECTIVE: To determine if extending sleep duration improves insulin sensitivity in&#xD;
      adolescents presenting with risk factors for type 2 diabetes.&#xD;
&#xD;
      HYPOTHESIS: It was hypothesized that compared with decreasing sleep duration, increasing&#xD;
      sleep duration by 1.5 hours over 1 week will improve insulin sensitivity.&#xD;
&#xD;
      METHODS: Using a randomized, counterbalanced, 2-condition crossover design, 30 obese&#xD;
      adolescents between 13 and 18 years of age who have insulin resistance will complete the&#xD;
      study. Participants will sleep their typical amount at home for 1 week and will then be&#xD;
      randomized to either increase or decrease their time in bed by 1.5 hours per night for 1&#xD;
      week, completing the alternate schedule on the fourth week (washout period of at least 1 week&#xD;
      between sleep conditions). This procedure will result in a targeted 3-hour time in bed&#xD;
      difference between conditions. Sleep will be objectively measured using actigraphy&#xD;
      (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and&#xD;
      wake times during the experimental weeks, and will be monitored through phone calls to the&#xD;
      research center. Participants will also be compensated for keeping the sleep schedule and&#xD;
      daily calls to enhance adherence. The outcome measures will then be compared between both&#xD;
      sleep conditions at the end (on day 8 of each study week). The primary outcome measure will&#xD;
      be insulin sensitivity as measured by the Matsuda index (total body insulin sensitivity).&#xD;
      Secondary outcomes will include the homeostasis model assessment of insulin resistance&#xD;
      (HOMA-IR), blood lipids, food intake and physical activity. Repeated measures analysis using&#xD;
      the mixed model will be used to assess the effect of the two sleep interventions on insulin&#xD;
      sensitivity.&#xD;
&#xD;
      RELEVANCE: The study will provide the first robust clinical evidence to determine if&#xD;
      increasing sleep duration in youth at risk for type 2 diabetes improves insulin sensitivity.&#xD;
      This information will be essential for clinical and public health guidelines for type 2&#xD;
      diabetes prevention among adolescents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2019</start_date>
  <completion_date type="Actual">December 12, 2021</completion_date>
  <primary_completion_date type="Actual">December 12, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_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)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>On day 8 of each sleep condition (2 time points)</time_frame>
    <description>Assessed by the Matsuda index during a 2-hour oral glucose tolerance test (OGTT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>On day 8 of each sleep condition (2 time points)</time_frame>
    <description>HOMA-IR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipids</measure>
    <time_frame>On day 8 of each sleep condition (2 time points)</time_frame>
    <description>HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food intake</measure>
    <time_frame>On days 5, 6 and 7 of each sleep condition (2 time points)</time_frame>
    <description>3-day dietary record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>During each 7-day sleep condition (2 time points)</time_frame>
    <description>Minutes per day of moderate-to-vigorous physical activity as assessed by accelerometry</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Sleep Extension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Increase in time in bed of 1.5 hours per night for one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Decrease in time in bed of 1.5 hours per night for one week</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep manipulation</intervention_name>
    <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.</description>
    <arm_group_label>Sleep Extension</arm_group_label>
    <arm_group_label>Sleep Restriction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents between the ages of 13 and 18 with obesity (body mass index greater than&#xD;
             the 95th percentile) and dyslipidemia (total cholesterol ≥ 200 mg/dL; low-density&#xD;
             lipoprotein cholesterol ≥ 130 mg/dL; non-high-density lipoprotein ≥ 145 mg/dL;&#xD;
             triglycerides ≥ 130 mg/dL; and high-density lipoprotein &lt; 40 mg/dL)&#xD;
&#xD;
          -  Adolescents who report between 6.5-8 hours of sleep per night will be eligible to&#xD;
             ensure that adolescents can extend and restrict sleep duration without reaching a&#xD;
             ceiling for what can be achieved (i.e. 8-10 hours/night of sleep is recommended at&#xD;
             this age) while limiting excessive sleep deprivation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of a chronic medical or psychiatric condition&#xD;
&#xD;
          -  Use of medications that could affect sleep or glucose homeostasis (e.g., metformin,&#xD;
             thyroid medication, stimulant medication, etc.)&#xD;
&#xD;
          -  History of sleep problems (e.g. sleep apnea).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Eastern Ontario Research Institute</investigator_affiliation>
    <investigator_full_name>Jean-Philippe Chaput</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03754036
org study id: 17/63X
nct id: NCT03754036
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention 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)
primary purpose: Prevention
masking: None (Open Label)
measure: Insulin sensitivity
time frame: On day 8 of each sleep condition (2 time points)
description: Assessed by the Matsuda index during a 2-hour oral glucose tolerance test (OGTT)
measure: Insulin sensitivity
time frame: On day 8 of each sleep condition (2 time points)
description: HOMA-IR
measure: Blood lipids
time frame: On day 8 of each sleep condition (2 time points)
description: HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol
measure: Food intake
time frame: On days 5, 6 and 7 of each sleep condition (2 time points)
description: 3-day dietary record
measure: Physical activity level
time frame: During each 7-day sleep condition (2 time points)
description: Minutes per day of moderate-to-vigorous physical activity as assessed by accelerometry
arm group label: Sleep Extension
arm group type: Experimental
description: Increase in time in bed of 1.5 hours per night for one week
arm group label: Sleep Restriction
arm group type: Experimental
description: Decrease in time in bed of 1.5 hours per night for one week
intervention type: Behavioral
intervention name: Sleep manipulation
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.
arm group label: Sleep Extension
arm group label: Sleep Restriction
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Eastern Ontario Research Institute
investigator full name: Jean-Philippe Chaput
investigator title: Research Scientist
mesh term: Insulin Resistance
sharing ipd: No