<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/NCT02998008</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1596</org_study_id>
    <nct_id>NCT02998008</nct_id>
  </id_info>
  <brief_title>Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes</brief_title>
  <official_title>Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Nord-Trøndelag HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</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>
      It is known from research that long-term exercise exposure in type 2 diabetes had positive&#xD;
      effects. However, the effect of acute exercise in a patient group with already reduced&#xD;
      cardiac function is not known.&#xD;
&#xD;
      In this study, the impact of acute exhaustive high intensity interval training on cardiac&#xD;
      function will be investigated in type 2 diabetes patients.&#xD;
&#xD;
      One single session of exhaustive high intensity interval exercise training is expected to&#xD;
      lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the&#xD;
      right ventricle of the heart is expected to be more affected than the left ventricle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    due to difficulties to attract participants&#xD;
  </why_stopped>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>echocardiography</measure>
    <time_frame>30 minutes each measurement per subject</time_frame>
    <description>peak longitudinal systolic tricuspid annular velocity in cm/s</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Diabetes type 2 patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>diabetes type 2 patients whose cardiac function is tested after 4x4 high intensity interval training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>healthy volunteers whose cardiac function is tested after 4x4 high intensity interval training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>high intensity interval training</intervention_name>
    <arm_group_label>Diabetes type 2 patients</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type II diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Øystein Risa, phd</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Circulation and Medical Imaging, NTNU</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>November 14, 2018</last_update_submitted>
  <last_update_submitted_qc>November 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise Therapy</keyword>
  <keyword>Heart Function Tests</keyword>
  <keyword>Heart/physiology</keyword>
  <keyword>Echocardiography</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>
  <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/NCT02998008
org study id: 2016/1596
nct id: NCT02998008
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is known from research that long-term exercise exposure in type 2 diabetes had positive
      effects. However, the effect of acute exercise in a patient group with already reduced
      cardiac function is not known.

      In this study, the impact of acute exhaustive high intensity interval training on cardiac
      function will be investigated in type 2 diabetes patients.

      One single session of exhaustive high intensity interval exercise training is expected to
      lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the
      right ventricle of the heart is expected to be more affected than the left ventricle.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: echocardiography
time frame: 30 minutes each measurement per subject
description: peak longitudinal systolic tricuspid annular velocity in cm/s
arm group label: Diabetes type 2 patients
arm group type: Other
description: diabetes type 2 patients whose cardiac function is tested after 4x4 high intensity interval training
arm group label: Healthy volunteers
arm group type: Other
description: healthy volunteers whose cardiac function is tested after 4x4 high intensity interval training
intervention type: Behavioral
intervention name: high intensity interval training
arm group label: Diabetes type 2 patients
arm group label: Healthy volunteers
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Øystein Risa, phd
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided