<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/NCT03299790</url>
  </required_header>
  <id_info>
    <org_study_id>HITDCM01</org_study_id>
    <nct_id>NCT03299790</nct_id>
  </id_info>
  <brief_title>Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy</brief_title>
  <official_title>Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</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>
      According to data of the International Diabetes Federation (IDF), diabetes in general affects&#xD;
      approximately 415 million people worldwide and this number is still increasing.&#xD;
      Cardiovascular diseases, one of the major complications of diabetes, are the leading cause of&#xD;
      mortality and morbidity in the diabetic population. One of the cardiovascular complications&#xD;
      is diabetic cardiomyopathy, in which structural and functional changes occur in the heart&#xD;
      impairing cardiac function.&#xD;
&#xD;
      Exercise training has already proven the benefits on glycemic control in diabetes. This is&#xD;
      also the case for the effects on cardiac function. However, as results are conflicting, it&#xD;
      remains unclear which elements of exercise training should be focused on. For instance,&#xD;
      high-intensity interval training (HIIT) is gaining interest as positive effects are already&#xD;
      shown on glycemic control. Therefore, the potential of HIIT to improve cardiac function in&#xD;
      diabetes should be investigated. Further on, the effects of exercise training on cardiac&#xD;
      function are mainly investigated during rest by the use of transthoracic echocardiography.&#xD;
      Therefore, as data are lacking, it remains unclear how the diabetic heart functions during&#xD;
      exercise.&#xD;
&#xD;
      The aim of the present study is to investigate the effects of different training modalities&#xD;
      (e.g. HIIT) on heart function in diabetes both during rest and during exercise itself.&#xD;
      Therefore, cardiac function will be evaluated by the use transthoracic (exercise)&#xD;
      echocardiography. This will be combined by the evaluation of several biochemical parameters.&#xD;
&#xD;
      The results will provide more insight in the pathology of diabetic cardiomyopathy as well as&#xD;
      the potential of exercise training for this cardiovascular complication. Eventually, this&#xD;
      research will contribute to the optimization of exercise programs for patients with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2017</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transthoracic echocardiography (TTE) during excercise</measure>
    <time_frame>day 1</time_frame>
    <description>heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transthoracic echocardiography (TTE) during excercise</measure>
    <time_frame>month 3</time_frame>
    <description>heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transthoracic echocardiography (TTE) during excercise</measure>
    <time_frame>month 6</time_frame>
    <description>heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transthoracic echocardiography (TTE) during excercise</measure>
    <time_frame>month 12</time_frame>
    <description>heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transthoracic echocardiography (TTE)</measure>
    <time_frame>day 1</time_frame>
    <description>heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transthoracic echocardiography (TTE)</measure>
    <time_frame>month 3</time_frame>
    <description>heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transthoracic echocardiography (TTE)</measure>
    <time_frame>month 6</time_frame>
    <description>heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transthoracic echocardiography (TTE)</measure>
    <time_frame>month 12</time_frame>
    <description>heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG (Electrocardiogram) during excercise</measure>
    <time_frame>month 3</time_frame>
    <description>ECG during excercise (an incremental exercise test on a cycle)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG (Electrocardiogram) during excercise</measure>
    <time_frame>month 12</time_frame>
    <description>ECG during excercise (an incremental exercise test on a cycle)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG (Electrocardiogram)</measure>
    <time_frame>month 3</time_frame>
    <description>ECG in rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG (Electrocardiogram)</measure>
    <time_frame>month 12</time_frame>
    <description>ECG in rest</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>day 1</time_frame>
    <description>glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>month 3</time_frame>
    <description>glycemic control, insulin sensitivity, inflammation, cardiac biomarkers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>month 6</time_frame>
    <description>glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>month 12</time_frame>
    <description>glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin metabolism</measure>
    <time_frame>day 1</time_frame>
    <description>Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin metabolism</measure>
    <time_frame>month 3</time_frame>
    <description>Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin metabolism</measure>
    <time_frame>month 6</time_frame>
    <description>Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin metabolism</measure>
    <time_frame>month 12</time_frame>
    <description>Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac function</measure>
    <time_frame>day 1</time_frame>
    <description>Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac function</measure>
    <time_frame>month 3</time_frame>
    <description>Cardiac biomarkers (BNP levels, cardiac troponin levels)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac function</measure>
    <time_frame>month 6</time_frame>
    <description>Cardiac biomarkers (BNP levels, cardiac troponin levels)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac function</measure>
    <time_frame>month 12</time_frame>
    <description>Cardiac biomarkers (BNP levels, cardiac troponin levels)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation and oxidative stress</measure>
    <time_frame>day 1</time_frame>
    <description>C reactive protein (CRP) levels, tumor necrosis factor-(TNF)alpha levels, interleukin (IL)-10 (interleukin) levels, oxidative stress markers (superoxide dismutase (SOD), malondialdehyde (MDA), glutathione peroxidase (GPX))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation and oxidative stress</measure>
    <time_frame>month 3</time_frame>
    <description>CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation and oxidative stress</measure>
    <time_frame>month 6</time_frame>
    <description>CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation and oxidative stress</measure>
    <time_frame>month 12</time_frame>
    <description>CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition</measure>
    <time_frame>day 1</time_frame>
    <description>body composition, measured using dual x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition</measure>
    <time_frame>month 6</time_frame>
    <description>body composition, measured using dual x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal oxygen uptake (ml/O2/kg/min)</measure>
    <time_frame>day 1</time_frame>
    <description>exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal oxygen uptake (ml/O2/kg/min)</measure>
    <time_frame>month 3</time_frame>
    <description>exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal oxygen uptake (ml/O2/kg/min)</measure>
    <time_frame>month 6</time_frame>
    <description>exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal oxygen uptake (ml/O2/kg/min)</measure>
    <time_frame>month 12</time_frame>
    <description>exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Diabetic Cardiomyopathies</condition>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>training group 1: HIIT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>high-intensity interval exercise training group (T2DM patients)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>training group 2: MIT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>moderate-intensity exercise training group (T2DM patients)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Detraining period</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Follow-up: detraining of group 1 and 2 (T2DM patients)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high-intensity interval exercise training (HIIT)</intervention_name>
    <description>This program includes 24 weeks of exercise training and is divided in different phases (phase 1: week 1-2, equal to the MIT group, phase 2: week 3-6, 6 bouts of high-intensity exercise, phase 3: week 7-12, 7 bouts of high-intensity exercise, phase 4: week 13-24, 8 bouts of high-intensity exercise). The exercise training program consists of 3 exercise sessions per week (for 6 months).</description>
    <arm_group_label>training group 1: HIIT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>moderate-intensity exercise training (MIT)</intervention_name>
    <description>This program includes 24 weeks of exercise training and is not devided in phases. The exercise training program consists of 3 endurance exercise sessions per week (for 6 months). The total exercise volume equals the exercise volume of the HIIT group.</description>
    <arm_group_label>training group 2: MIT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 2 diabetes patients:&#xD;
&#xD;
               -  BMI &gt; 20kg/m²&#xD;
&#xD;
               -  diagnosis of T2DM as stated in guidelines of ADA (American Diabetes Association)&#xD;
&#xD;
               -  stable medication for at least 3 months&#xD;
&#xD;
          -  Healthy controls:&#xD;
&#xD;
               -  BMI &gt; 20kg/m²&#xD;
&#xD;
               -  no diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  iron deficiency anemia&#xD;
&#xD;
          -  participation in another clinical trial&#xD;
&#xD;
          -  heart diseases: CAD (coronary artery disease), ischemia, valvular diseases, congenital&#xD;
             heart diseases&#xD;
&#xD;
          -  neurological, pneumological, oncological, orthopedic disorders&#xD;
&#xD;
          -  diabetes complications: renal diseases, retinopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>81 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>December 9, 2020</last_update_submitted>
  <last_update_submitted_qc>December 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Dominique Hansen</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Diabetic cardiomyopathy</keyword>
  <keyword>Cardiac function</keyword>
  <keyword>Exercise echocardiography</keyword>
  <keyword>Exercise training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Diabetic Cardiomyopathies</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/NCT03299790
org study id: HITDCM01
nct id: NCT03299790
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
According to data of the International Diabetes Federation (IDF), diabetes in general affects
      approximately 415 million people worldwide and this number is still increasing.
      Cardiovascular diseases, one of the major complications of diabetes, are the leading cause of
      mortality and morbidity in the diabetic population. One of the cardiovascular complications
      is diabetic cardiomyopathy, in which structural and functional changes occur in the heart
      impairing cardiac function.

      Exercise training has already proven the benefits on glycemic control in diabetes. This is
      also the case for the effects on cardiac function. However, as results are conflicting, it
      remains unclear which elements of exercise training should be focused on. For instance,
      high-intensity interval training (HIIT) is gaining interest as positive effects are already
      shown on glycemic control. Therefore, the potential of HIIT to improve cardiac function in
      diabetes should be investigated. Further on, the effects of exercise training on cardiac
      function are mainly investigated during rest by the use of transthoracic echocardiography.
      Therefore, as data are lacking, it remains unclear how the diabetic heart functions during
      exercise.

      The aim of the present study is to investigate the effects of different training modalities
      (e.g. HIIT) on heart function in diabetes both during rest and during exercise itself.
      Therefore, cardiac function will be evaluated by the use transthoracic (exercise)
      echocardiography. This will be combined by the evaluation of several biochemical parameters.

      The results will provide more insight in the pathology of diabetic cardiomyopathy as well as
      the potential of exercise training for this cardiovascular complication. Eventually, this
      research will contribute to the optimization of exercise programs for patients with diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Transthoracic echocardiography (TTE) during excercise
time frame: day 1
description: heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
measure: Transthoracic echocardiography (TTE) during excercise
time frame: month 3
description: heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
measure: Transthoracic echocardiography (TTE) during excercise
time frame: month 6
description: heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
measure: Transthoracic echocardiography (TTE) during excercise
time frame: month 12
description: heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
measure: Transthoracic echocardiography (TTE)
time frame: day 1
description: heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
measure: Transthoracic echocardiography (TTE)
time frame: month 3
description: heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
measure: Transthoracic echocardiography (TTE)
time frame: month 6
description: heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
measure: Transthoracic echocardiography (TTE)
time frame: month 12
description: heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
measure: ECG (Electrocardiogram) during excercise
time frame: month 3
description: ECG during excercise (an incremental exercise test on a cycle)
measure: ECG (Electrocardiogram) during excercise
time frame: month 12
description: ECG during excercise (an incremental exercise test on a cycle)
measure: ECG (Electrocardiogram)
time frame: month 3
description: ECG in rest
measure: ECG (Electrocardiogram)
time frame: month 12
description: ECG in rest
measure: Glycemic control
time frame: day 1
description: glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
measure: Glycemic control
time frame: month 3
description: glycemic control, insulin sensitivity, inflammation, cardiac biomarkers
measure: Glycemic control
time frame: month 6
description: glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
measure: Glycemic control
time frame: month 12
description: glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
measure: Insulin metabolism
time frame: day 1
description: Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
measure: Insulin metabolism
time frame: month 3
description: Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
measure: Insulin metabolism
time frame: month 6
description: Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
measure: Insulin metabolism
time frame: month 12
description: Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
measure: Cardiac function
time frame: day 1
description: Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)
measure: Cardiac function
time frame: month 3
description: Cardiac biomarkers (BNP levels, cardiac troponin levels)
measure: Cardiac function
time frame: month 6
description: Cardiac biomarkers (BNP levels, cardiac troponin levels)
measure: Cardiac function
time frame: month 12
description: Cardiac biomarkers (BNP levels, cardiac troponin levels)
measure: Inflammation and oxidative stress
time frame: day 1
description: C reactive protein (CRP) levels, tumor necrosis factor-(TNF)alpha levels, interleukin (IL)-10 (interleukin) levels, oxidative stress markers (superoxide dismutase (SOD), malondialdehyde (MDA), glutathione peroxidase (GPX))
measure: Inflammation and oxidative stress
time frame: month 3
description: CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
measure: Inflammation and oxidative stress
time frame: month 6
description: CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)
measure: Inflammation and oxidative stress
time frame: month 12
description: CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
measure: body composition
time frame: day 1
description: body composition, measured using dual x-ray absorptiometry
measure: body composition
time frame: month 6
description: body composition, measured using dual x-ray absorptiometry
measure: Maximal oxygen uptake (ml/O2/kg/min)
time frame: day 1
description: exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
measure: Maximal oxygen uptake (ml/O2/kg/min)
time frame: month 3
description: exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
measure: Maximal oxygen uptake (ml/O2/kg/min)
time frame: month 6
description: exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
measure: Maximal oxygen uptake (ml/O2/kg/min)
time frame: month 12
description: exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
arm group label: training group 1: HIIT
arm group type: Active Comparator
description: high-intensity interval exercise training group (T2DM patients)
arm group label: training group 2: MIT
arm group type: Active Comparator
description: moderate-intensity exercise training group (T2DM patients)
arm group label: Detraining period
arm group type: No Intervention
description: Follow-up: detraining of group 1 and 2 (T2DM patients)
arm group label: Healthy controls
arm group type: No Intervention
intervention type: Other
intervention name: high-intensity interval exercise training (HIIT)
description: This program includes 24 weeks of exercise training and is divided in different phases (phase 1: week 1-2, equal to the MIT group, phase 2: week 3-6, 6 bouts of high-intensity exercise, phase 3: week 7-12, 7 bouts of high-intensity exercise, phase 4: week 13-24, 8 bouts of high-intensity exercise). The exercise training program consists of 3 exercise sessions per week (for 6 months).
arm group label: training group 1: HIIT
intervention type: Other
intervention name: moderate-intensity exercise training (MIT)
description: This program includes 24 weeks of exercise training and is not devided in phases. The exercise training program consists of 3 endurance exercise sessions per week (for 6 months). The total exercise volume equals the exercise volume of the HIIT group.
arm group label: training group 2: MIT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 81 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Dominique Hansen
investigator title: prof. dr.
mesh term: Cardiomyopathies
mesh term: Diabetic Cardiomyopathies
mesh term: Diabetes Mellitus, Type 2