<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/NCT01732705</url>
  </required_header>
  <id_info>
    <org_study_id>HIT-T2DM</org_study_id>
    <nct_id>NCT01732705</nct_id>
  </id_info>
  <brief_title>High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes</brief_title>
  <acronym>HIT_T2DM</acronym>
  <official_title>Effect of High Intensity Interval Training (HIT) on Insulin Sensitivity in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ministry of Science, Technology and Innovation, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of High Intensity Interval Training&#xD;
      (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in&#xD;
      individuals with type 2 diabetes, but implies a considerable time commitment. High intensity&#xD;
      interval training (HIT) is time-efficient exercise consisting of repeated bouts of short&#xD;
      duration high intensive workloads. The aim of this study is to determine the effect of HIT in&#xD;
      patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of&#xD;
      HIT.&#xD;
&#xD;
      Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg&#xD;
      serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be&#xD;
      measured after completion of the overall training program by euglycemic hyperinsulinemic&#xD;
      clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during&#xD;
      training period for measuring of muscle glycogen content, and muscle biopsies for further&#xD;
      analysis obtained during the experimental day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>2 days after last training session (day 17)</time_frame>
    <description>Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Glycogen content in skeletal muscle</measure>
    <time_frame>17 days. Before and after training session day 1, 7 and 15. Before and immediately after isoglycemic, hyperinsulinemic clamp day 17.</time_frame>
    <description>Analysis of glycogen content from muscle biopsies taken during the training period.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>HIT (trained leg) DM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High intensity interval training for one leg (trained leg) (randomized) in patient with type 2 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control leg, DM</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control leg (untrained leg)in patient with type 2 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIT (trained leg), Control subject</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High intensity interval training for one leg (trained leg) (randomized) in control subject</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control leg, Control subject</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control leg (untrained leg)in control subject</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intensity interval training</intervention_name>
    <description>HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.</description>
    <arm_group_label>HIT (trained leg) DM</arm_group_label>
    <arm_group_label>HIT (trained leg), Control subject</arm_group_label>
    <other_name>High intense interval training</other_name>
    <other_name>HIT</other_name>
    <other_name>HIIT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10 subjects with Type 2 diabetes. 10 healthy control subjects.&#xD;
&#xD;
          -  BMI 28-35&#xD;
&#xD;
          -  diet or tablet treatment for diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  regular physical activity&#xD;
&#xD;
          -  diseases other than type 2 diabetes&#xD;
&#xD;
          -  insulin treatment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Flemming Dela, MD. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xlab, Department of Biomedical Sciences, University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xlab, Department of Biomedical Sciences, University of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>2200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Flemming Dela</investigator_full_name>
    <investigator_title>Professor, MD.</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Insulin sensitivity</keyword>
  <keyword>High intensity interval training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <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/NCT01732705
org study id: HIT-T2DM
nct id: NCT01732705
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the effect of High Intensity Interval Training
      (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.
Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in
      individuals with type 2 diabetes, but implies a considerable time commitment. High intensity
      interval training (HIT) is time-efficient exercise consisting of repeated bouts of short
      duration high intensive workloads. The aim of this study is to determine the effect of HIT in
      patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of
      HIT.

      Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg
      serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be
      measured after completion of the overall training program by euglycemic hyperinsulinemic
      clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during
      training period for measuring of muscle glycogen content, and muscle biopsies for further
      analysis obtained during the experimental day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Insulin sensitivity
time frame: 2 days after last training session (day 17)
description: Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs.
measure: Glycogen content in skeletal muscle
time frame: 17 days. Before and after training session day 1, 7 and 15. Before and immediately after isoglycemic, hyperinsulinemic clamp day 17.
description: Analysis of glycogen content from muscle biopsies taken during the training period.
arm group label: HIT (trained leg) DM
arm group type: Experimental
description: High intensity interval training for one leg (trained leg) (randomized) in patient with type 2 diabetes
arm group label: Control leg, DM
arm group type: No Intervention
description: Control leg (untrained leg)in patient with type 2 diabetes
arm group label: HIT (trained leg), Control subject
arm group type: Experimental
description: High intensity interval training for one leg (trained leg) (randomized) in control subject
arm group label: Control leg, Control subject
arm group type: No Intervention
description: Control leg (untrained leg)in control subject
intervention type: Behavioral
intervention name: High intensity interval training
description: HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.
arm group label: HIT (trained leg) DM
arm group label: HIT (trained leg), Control subject
other name: High intense interval training
other name: HIT
other name: HIIT
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Flemming Dela, MD. Prof.
role: Principal Investigator
affiliation: Xlab, Department of Biomedical Sciences, University of Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Flemming Dela
investigator title: Professor, MD.
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2