<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/NCT02257190</url>
  </required_header>
  <id_info>
    <org_study_id>H-1-2014-060</org_study_id>
    <nct_id>NCT02257190</nct_id>
  </id_info>
  <brief_title>The Features Behind the Beneficial Effects of Interval-walking</brief_title>
  <acronym>aIWS2</acronym>
  <official_title>The Features Behind the Beneficial Effects of Interval-walking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and&#xD;
      time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The&#xD;
      reason IW is superior is unknown.&#xD;
&#xD;
      This study will look into whether it is the larger peak intensity during IW or if it is the&#xD;
      alternating exercise pattern that is responsible for the larger improvements seen.&#xD;
&#xD;
      Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled&#xD;
      study, where each subject will undergo three trials. Trials will be identical except the&#xD;
      following interventions:&#xD;
&#xD;
        1. One hour of rest (Con)&#xD;
&#xD;
        2. One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of&#xD;
           slow walking; IW3)&#xD;
&#xD;
        3. One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1&#xD;
           min of slow walking; IW1).&#xD;
&#xD;
      After the interventions subjects will undergo a standardized mixed meal tolerance test, with&#xD;
      consecutive measurements of blood glucose, insulin and c-peptide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>Within the first 4 hours after the interventions</time_frame>
    <description>Glycemic control will be measured after each intervention. Subjects will receive a standardized mixed meal tolerance test (MMTT), and blood glucose values will be obtained during the test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin secretion</measure>
    <time_frame>Within the first 4 hours after the interventions</time_frame>
    <description>Insulin and C-peptide will be measured during the MMTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>Within the first 4 hours after the interventions</time_frame>
    <description>From the measurements og glucose and insulin during the MMTT, various indices of insulin sensitivity will be assessed</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Control (Con)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No exercise intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interval Walking - 3 min intervals (IW3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One hour of classical interval walking exercise (repeated cycles of 3 min of fast and 3 min of slow walking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interval Walking - 1 min intervals (IW1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One hour of fast alternating interval walking exercise (repeated cycles of 3 min of fast and 3 min of slow walking</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>One hour of rest.</description>
    <arm_group_label>Control (Con)</arm_group_label>
    <other_name>No exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IW3</intervention_name>
    <description>A one hour exercise bout with repeated cycles of 3 min of fast and 3 min of slow walking</description>
    <arm_group_label>Interval Walking - 3 min intervals (IW3)</arm_group_label>
    <other_name>'Classical' interval walking</other_name>
    <other_name>Interval walking - 3 min intervals</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IW1</intervention_name>
    <description>A one hour exercise bout with repeated cycles of 1 min of fast and 1 min of slow walking</description>
    <arm_group_label>Interval Walking - 1 min intervals (IW1)</arm_group_label>
    <other_name>'Fast alternating' interval walking</other_name>
    <other_name>Interval walking - 1 min intervals</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus&#xD;
&#xD;
          -  Body mass index &gt; 18 but &lt; 40 m2/kg&#xD;
&#xD;
          -  Agreement to pause antidiabetic medication from 2 days before to after each trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Use of exogenous insulin&#xD;
&#xD;
          -  Contraindication to increased levels of physical activity&#xD;
&#xD;
          -  Evidence of thyroid, liver, lung, heart or kidney disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristian Karstoft, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Physical Activity Research, Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Physical Activity Research (CFAS)</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 28, 2015</last_update_submitted>
  <last_update_submitted_qc>October 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Anders Rasmussen Rinnov</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Glycemic control</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02257190
org study id: H-1-2014-060
nct id: NCT02257190
lead sponsor: 
has dmc: No
A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and
      time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The
      reason IW is superior is unknown.

      This study will look into whether it is the larger peak intensity during IW or if it is the
      alternating exercise pattern that is responsible for the larger improvements seen.

      Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled
      study, where each subject will undergo three trials. Trials will be identical except the
      following interventions:

        1. One hour of rest (Con)

        2. One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of
           slow walking; IW3)

        3. One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1
           min of slow walking; IW1).

      After the interventions subjects will undergo a standardized mixed meal tolerance test, with
      consecutive measurements of blood glucose, insulin and c-peptide.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glycemic control
time frame: Within the first 4 hours after the interventions
description: Glycemic control will be measured after each intervention. Subjects will receive a standardized mixed meal tolerance test (MMTT), and blood glucose values will be obtained during the test.
measure: Insulin secretion
time frame: Within the first 4 hours after the interventions
description: Insulin and C-peptide will be measured during the MMTT
measure: Insulin sensitivity
time frame: Within the first 4 hours after the interventions
description: From the measurements og glucose and insulin during the MMTT, various indices of insulin sensitivity will be assessed
arm group label: Control (Con)
arm group type: Experimental
description: No exercise intervention.
arm group label: Interval Walking - 3 min intervals (IW3)
arm group type: Experimental
description: One hour of classical interval walking exercise (repeated cycles of 3 min of fast and 3 min of slow walking.
arm group label: Interval Walking - 1 min intervals (IW1)
arm group type: Experimental
description: One hour of fast alternating interval walking exercise (repeated cycles of 3 min of fast and 3 min of slow walking
intervention type: Behavioral
intervention name: Control
description: One hour of rest.
arm group label: Control (Con)
other name: No exercise
intervention type: Behavioral
intervention name: IW3
description: A one hour exercise bout with repeated cycles of 3 min of fast and 3 min of slow walking
arm group label: Interval Walking - 3 min intervals (IW3)
other name: 'Classical' interval walking
other name: Interval walking - 3 min intervals
intervention type: Behavioral
intervention name: IW1
description: A one hour exercise bout with repeated cycles of 1 min of fast and 1 min of slow walking
arm group label: Interval Walking - 1 min intervals (IW1)
other name: 'Fast alternating' interval walking
other name: Interval walking - 1 min intervals
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Kristian Karstoft, MD, PhD
role: Principal Investigator
affiliation: Centre for Physical Activity Research, Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Anders Rasmussen Rinnov
investigator title: MD, PhD
mesh term: Diabetes Mellitus, Type 2