<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/NCT02229487</url>
  </required_header>
  <id_info>
    <org_study_id>08-57-16</org_study_id>
    <nct_id>NCT02229487</nct_id>
  </id_info>
  <brief_title>The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers</brief_title>
  <acronym>Sleep GLP-1</acronym>
  <official_title>The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ramathibodi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ramathibodi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis&#xD;
&#xD;
        1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than&#xD;
           those with normal sleep duration.&#xD;
&#xD;
        2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a&#xD;
           standardized meal&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GLP-1 Levels in Response to Oral Glucose Tolerance Test</measure>
    <time_frame>2 weeks</time_frame>
    <description>Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Normal Sleepers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short Sleepers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prediabetes patients with short sleep duration (&lt;6 hours/night) as measured objectively</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral glucose tolerance</intervention_name>
    <arm_group_label>Normal Sleepers</arm_group_label>
    <arm_group_label>Short Sleepers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with prediabetes (HbA1c 5.7-6.4% or history of fasting plasma glucose 100-125&#xD;
             mg/dl) who receive medical care at Ramathibodi Hospital&#xD;
&#xD;
          2. Age 18 or older&#xD;
&#xD;
          3. Can understand Thai (speaking, listening and reading)&#xD;
&#xD;
          4. Agree to participate by written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those who depend on others for feeding (such as stroke patients)&#xD;
&#xD;
          2. Shift workers&#xD;
&#xD;
          3. History of congestive heart failure or low ejection fraction&#xD;
&#xD;
          4. Chronic obstructive pulmonary disease, end stage renal disease or chronic liver&#xD;
             disease (AST or ALT &gt; 3 times the upper limit of normal)&#xD;
&#xD;
          5. Use of medications: opioids/ narcotics , alpha blockers (prazosin, doxazosin,&#xD;
             terazosin), clonidine, methyldopa, nitroglycerin&#xD;
&#xD;
          6. Patients with permanent pacemaker&#xD;
&#xD;
          7. History of previous stroke&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine Ramathibodi Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>May 1, 2017</results_first_submitted>
  <results_first_submitted_qc>May 1, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 14, 2017</results_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ramathibodi Hospital</investigator_affiliation>
    <investigator_full_name>Sirimon Reutrakul</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Prediabetes</keyword>
  <keyword>Short sleepers</keyword>
  <keyword>GLP-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 5, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT02229487/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Normal Sleepers</title>
          <description>Prediabetes patients with normal sleep duration (&gt;=6.5 hours/ night) as measured objectively&#xD;
Oral glucose tolerance</description>
        </group>
        <group group_id="P2">
          <title>Short Sleepers</title>
          <description>Prediabetes patients with short sleep duration (=&lt;5.75 hours/night) as measured objectively&#xD;
Oral glucose tolerance</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Normal Sleeper</title>
          <description>Sleep duration as measured by actigraphy &gt;=6.5 h/night</description>
        </group>
        <group group_id="B2">
          <title>Short Sleeper</title>
          <description>Sleep duration as measured by actigraphy =&lt;5.75 h/night</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="51"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.5" spread="9.8"/>
                    <measurement group_id="B2" value="55.8" spread="6.7"/>
                    <measurement group_id="B3" value="55.7" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Thai</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.7" spread="3.2"/>
                    <measurement group_id="B2" value="26.8" spread="3.8"/>
                    <measurement group_id="B3" value="26.8" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>GLP-1 Levels in Response to Oral Glucose Tolerance Test</title>
        <description>Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Short Sleepers</title>
            <description>Sleep duration as measured by actigraphy =&lt;5.75 h/night</description>
          </group>
          <group group_id="O2">
            <title>Normal Sleepers</title>
            <description>Sleep duration as measured by actigraphy &gt;=6.5h/night</description>
          </group>
        </group_list>
        <measure>
          <title>GLP-1 Levels in Response to Oral Glucose Tolerance Test</title>
          <description>Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels</description>
          <units>pmol/l.h</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.66" lower_limit="12.21" upper_limit="21.10"/>
                    <measurement group_id="O2" value="18.57" lower_limit="13.42" upper_limit="39.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.209</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Normal Sleeper</title>
          <description>Sleep duration as measured by actigraphy &gt;=6.5 h/night</description>
        </group>
        <group group_id="E2">
          <title>Short Sleeper</title>
          <description>Sleep duration as measured by actigraphy =&lt;5.7 h/night</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sirimon Reutrakul</name_or_title>
      <organization>Ramathibodii Hospital, Mahidol University</organization>
      <phone>66922011647 ext 708</phone>
      <email>sreutrakul@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02229487
org study id: 08-57-16
nct id: NCT02229487
lead sponsor: 
collaborator: 
has dmc: No
Hypothesis

        1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than
           those with normal sleep duration.

        2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a
           standardized meal
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: GLP-1 Levels in Response to Oral Glucose Tolerance Test
time frame: 2 weeks
description: Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels
arm group label: Normal Sleepers
arm group type: Active Comparator
description: Prediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively
arm group label: Short Sleepers
arm group type: Experimental
description: Prediabetes patients with short sleep duration (<6 hours/night) as measured objectively
intervention type: Other
intervention name: Oral glucose tolerance
arm group label: Normal Sleepers
arm group label: Short Sleepers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Ramathibodi Hospital
investigator full name: Sirimon Reutrakul
investigator title: Associate Professor
mesh term: Prediabetic State
mesh term: Glucose Intolerance
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 