<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/NCT02253368</url>
  </required_header>
  <id_info>
    <org_study_id>IRB14-0528</org_study_id>
    <nct_id>NCT02253368</nct_id>
  </id_info>
  <brief_title>Home Sleep and Metabolism</brief_title>
  <official_title>Home Sleep and Metabolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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>
      Bedtimes and wake-up times vary from person to person. The aim of this research is to examine&#xD;
      the associations between sleep habits and metabolism in healthy people. In this study, the&#xD;
      investigators will collect information on sleep-wake habits and how the body uses energy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">October 2020</completion_date>
  <primary_completion_date type="Actual">February 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in insulin sensitivity (SI)</measure>
    <time_frame>The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.</time_frame>
    <description>Insulin sensitivity will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in insulin sensitivity will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in total energy expenditure</measure>
    <time_frame>The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.</time_frame>
    <description>Total energy expenditure will be derived from doubly labeled water method. For each subject, total energy expenditure will be calculated during each 2-week period and then the change from the first 2-week period in total energy expenditure will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in energy intake</measure>
    <time_frame>The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.</time_frame>
    <description>Energy intake will be derived from doubly labeled water method and body composition analysis. For each subject, energy intake will be calculated during each 2-week period and then the change from the first 2-week period in energy intake will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in beta-cell function</measure>
    <time_frame>The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.</time_frame>
    <description>Beta cell function will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in beta-cell function will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in disposition index</measure>
    <time_frame>The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.</time_frame>
    <description>Disposition index will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in disposition index will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in body weight</measure>
    <time_frame>The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.</time_frame>
    <description>Weight will be derived from scale weight measurements. For each subject, their change in weight will be calculated during each period and then the change from the first 2-week period in body weight will be calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Overweight</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Sleep Arm 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sleep Arm 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sleep Arm 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sleep</intervention_name>
    <arm_group_label>Sleep Arm 1</arm_group_label>
    <arm_group_label>Sleep Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 21-40 years&#xD;
&#xD;
          -  Body mass index: 25.0 to 29.9 kg/m2&#xD;
&#xD;
          -  Average habitual sleep duration of 6.5 hours or less per night (as confirmed by&#xD;
             actigraphy)&#xD;
&#xD;
          -  stable sleep habits for the past 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  obstructive sleep apnea or history of any other sleep disorder&#xD;
&#xD;
          -  night or rotating shift work (current or in the past 2 years)&#xD;
&#xD;
          -  habitual daytime naps&#xD;
&#xD;
          -  recent (&lt; 4 week) travel across time zones&#xD;
&#xD;
          -  extreme chronotypes&#xD;
&#xD;
          -  any acute or chronic medical condition&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  prior or current eating or psychiatric disorders&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  irregular menstrual periods, menopause, pregnancy,&#xD;
&#xD;
          -  alcohol abuse, excessive caffeine intake, smoking, illegal drug use&#xD;
&#xD;
          -  subjects who are currently following a weight loss regimen or any other special diet&#xD;
             or exercise programs&#xD;
&#xD;
          -  subjects who have received iv or oral contrast in the past 2 weeks&#xD;
&#xD;
          -  use of any prescription medication that can affect sleep or metabolism with the&#xD;
             exception of antihypertensive and lipid lowering agents as follows. Subjects who are&#xD;
             taking anti-hypertensive medication and/or lipid-lowering agents will be included only&#xD;
             if they are well controlled and on a stable regimen (no change in medications in the&#xD;
             previous 3 months). However, beta-blockers and thiazide diuretics will not be allowed,&#xD;
             as these medications are known to affect insulin sensitivity. Women will be required&#xD;
             to not be on hormone replacement therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esra Tasali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT02253368/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>March 3, 2022</submitted>
    <returned>May 19, 2022</returned>
    <submitted>June 3, 2022</submitted>
    <returned>March 14, 2023</returned>
  </pending_results>
  <!-- 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/NCT02253368
org study id: IRB14-0528
nct id: NCT02253368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bedtimes and wake-up times vary from person to person. The aim of this research is to examine
      the associations between sleep habits and metabolism in healthy people. In this study, the
      investigators will collect information on sleep-wake habits and how the body uses energy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change from Baseline in insulin sensitivity (SI)
time frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
description: Insulin sensitivity will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in insulin sensitivity will be calculated.
measure: Change from Baseline in total energy expenditure
time frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
description: Total energy expenditure will be derived from doubly labeled water method. For each subject, total energy expenditure will be calculated during each 2-week period and then the change from the first 2-week period in total energy expenditure will be calculated.
measure: Change from Baseline in energy intake
time frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
description: Energy intake will be derived from doubly labeled water method and body composition analysis. For each subject, energy intake will be calculated during each 2-week period and then the change from the first 2-week period in energy intake will be calculated.
measure: Change from Baseline in beta-cell function
time frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
description: Beta cell function will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in beta-cell function will be calculated.
measure: Change from Baseline in disposition index
time frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
description: Disposition index will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in disposition index will be calculated.
measure: Change from Baseline in body weight
time frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
description: Weight will be derived from scale weight measurements. For each subject, their change in weight will be calculated during each period and then the change from the first 2-week period in body weight will be calculated.
arm group label: Sleep Arm 1
arm group type: Active Comparator
description: Sleep Arm 1
arm group label: Sleep Arm 2
arm group type: Active Comparator
description: Sleep Arm 2
intervention type: Other
intervention name: sleep
arm group label: Sleep Arm 1
arm group label: Sleep Arm 2
criteria: 
gender: All
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Esra Tasali, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
provided document: 
submitted: March 3, 2022
returned: May 19, 2022
submitted: June 3, 2022
returned: March 14, 2023