<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/NCT03814512</url>
  </required_header>
  <id_info>
    <org_study_id>18-2396</org_study_id>
    <nct_id>NCT03814512</nct_id>
  </id_info>
  <brief_title>Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents</brief_title>
  <acronym>REM</acronym>
  <official_title>Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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>
      The investigators propose to deliver a 4-week sleep extension intervention to adolescents to&#xD;
      evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes&#xD;
      in metabolic parameters induced by sleep extension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims of this feasibility study are to 1) examine the feasibility of recruitment&#xD;
      and retention of adolescents with overweight/obesity, pre-diabetes, and inadequate sleep into&#xD;
      a sleep extension intervention; 2) assess adherence of a sleep extension intervention to&#xD;
      increase total sleep time in adolescents with overweight/obesity, pre-diabetes, and&#xD;
      inadequate sleep; 3) determine estimates of mean and variability of potential intervention&#xD;
      outcomes including metabolomic, body composition, and substrate oxidation. The investigators&#xD;
      propose to deliver a 4-week sleep extension intervention to adolescents to evaluate&#xD;
      feasibility of the protocol and obtain preliminary data on intra-individual changes in&#xD;
      metabolic parameters induced by sleep extension.&#xD;
&#xD;
      This proposal is the first step to demonstrate feasibility in delivering the intervention in&#xD;
      a research setting, measure the effect of the intervention on changing sleep duration, and&#xD;
      examine changes in obesity-related IR metabolites that would lead to improved IR in an&#xD;
      adolescent population with pre-diabetes. The long-term goal is to disseminate an effective&#xD;
      and feasible T2D prevention program that can be sustainably implemented in clinical weight&#xD;
      management settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 21, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">April 20, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a pilot study testing the intervention arm of the RCT. No control group.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Total Sleep Time</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Sleep</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Extended Sleep Intervention (ES)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a Standard Care Diet and Physical Activity Education Intervention (SC) and an Extended Sleep Intervention (ES). For the SC, participants will have their diet, physical activity, and screen time assessed by study interventionist. Prescribed goals will be determined collaboratively through discussion with participants and parents. For the ES, participants will subsequently be prescribed a sleep schedule that allows them to obtain 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Extended Sleep Intervention</intervention_name>
    <description>Participants will receive an Extended Sleep Intervention (ES). Participants will be prescribed a sleep schedule that allows them to obtain approximately 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively through discussion with participants and parents.</description>
    <arm_group_label>Extended Sleep Intervention (ES)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. High school students between the age of 13-19 years&#xD;
&#xD;
          2. BMI &gt;85th percentile for age and sex&#xD;
&#xD;
          3. Prediabetes defined as a HbA1c 5.7-6.4%&#xD;
&#xD;
          4. Tanner Stage 4-5 (based on breast development for girls and testicular size for boys)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any medications that affect insulin resistance or sleep (e.g., metformin, stimulants,&#xD;
             atypical antipsychotics, current use of oral steroids)&#xD;
&#xD;
          2. Regular use of melatonin or other sleep aids&#xD;
&#xD;
          3. A prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome,&#xD;
             obstructive sleep apnea) or abnormal scores on sleep disorders screening measures&#xD;
&#xD;
          4. Type 2 diabetes (HbA1c ≥ 6.5%)&#xD;
&#xD;
          5. IQ&lt;70 or severe mental illness that may impact sleep or ability to consent/assent&#xD;
             (e.g., schizophrenia, psychotic episodes), verified through chart review&#xD;
&#xD;
          6. Teens not enrolled in a traditional high school academic program (e.g., home school&#xD;
             students)&#xD;
&#xD;
          7. Schedules that would preclude participants from adhering to the sleep extension&#xD;
             protocol (e.g. night shift employment)&#xD;
&#xD;
          8. Travel across more than two time zones in the 2 weeks prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Lafayette</city>
        <state>Colorado</state>
        <zip>80026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</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>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03814512
org study id: 18-2396
nct id: NCT03814512
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators propose to deliver a 4-week sleep extension intervention to adolescents to
      evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes
      in metabolic parameters induced by sleep extension.
The specific aims of this feasibility study are to 1) examine the feasibility of recruitment
      and retention of adolescents with overweight/obesity, pre-diabetes, and inadequate sleep into
      a sleep extension intervention; 2) assess adherence of a sleep extension intervention to
      increase total sleep time in adolescents with overweight/obesity, pre-diabetes, and
      inadequate sleep; 3) determine estimates of mean and variability of potential intervention
      outcomes including metabolomic, body composition, and substrate oxidation. The investigators
      propose to deliver a 4-week sleep extension intervention to adolescents to evaluate
      feasibility of the protocol and obtain preliminary data on intra-individual changes in
      metabolic parameters induced by sleep extension.

      This proposal is the first step to demonstrate feasibility in delivering the intervention in
      a research setting, measure the effect of the intervention on changing sleep duration, and
      examine changes in obesity-related IR metabolites that would lead to improved IR in an
      adolescent population with pre-diabetes. The long-term goal is to disseminate an effective
      and feasible T2D prevention program that can be sustainably implemented in clinical weight
      management settings.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a pilot study testing the intervention arm of the RCT. No control group.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Total Sleep Time
time frame: up to 12 weeks
description: The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention
arm group label: Extended Sleep Intervention (ES)
arm group type: Experimental
description: Participants will receive a Standard Care Diet and Physical Activity Education Intervention (SC) and an Extended Sleep Intervention (ES). For the SC, participants will have their diet, physical activity, and screen time assessed by study interventionist. Prescribed goals will be determined collaboratively through discussion with participants and parents. For the ES, participants will subsequently be prescribed a sleep schedule that allows them to obtain 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively.
intervention type: Behavioral
intervention name: Extended Sleep Intervention
description: Participants will receive an Extended Sleep Intervention (ES). Participants will be prescribed a sleep schedule that allows them to obtain approximately 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively through discussion with participants and parents.
arm group label: Extended Sleep Intervention (ES)
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Resistance
sharing ipd: Undecided