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Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT03299790
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Dominique Hansen, Hasselt University

September 12, 2017
October 3, 2017
October 9, 2017
October 6, 2017
December 31, 2018   (Final data collection date for primary outcome measure)
  • Transthoracic echocardiography (TTE) during excercise [ Time Frame: day 1 ]
    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,…)
  • Transthoracic echocardiography (TTE) during excercise [ Time Frame: month 3 ]
    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,…)
  • Transthoracic echocardiography (TTE) during excercise [ Time Frame: month 6 ]
    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,…)
  • Transthoracic echocardiography (TTE) during excercise [ Time Frame: month 12 ]
    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,…)
  • Transthoracic echocardiography (TTE) [ Time Frame: day 1 ]
    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,…)
  • Transthoracic echocardiography (TTE) [ Time Frame: month 3 ]
    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,…)
  • Transthoracic echocardiography (TTE) [ Time Frame: month 6 ]
    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,…)
  • Transthoracic echocardiography (TTE) [ Time Frame: month 12 ]
    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,…)
  • ECG (Electrocardiogram) during excercise [ Time Frame: month 3 ]
    ECG during excercise (an incremental exercise test on a cycle)
  • ECG (Electrocardiogram) during excercise [ Time Frame: month 12 ]
    ECG during excercise (an incremental exercise test on a cycle)
  • ECG (Electrocardiogram) [ Time Frame: month 3 ]
    ECG in rest
  • ECG (Electrocardiogram) [ Time Frame: month 12 ]
    ECG in rest
Same as current
Complete list of historical versions of study NCT03299790 on ClinicalTrials.gov Archive Site
  • Glycemic control [ Time Frame: day 1 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
  • Glycemic control [ Time Frame: month 3 ]
    glycemic control, insulin sensitivity, inflammation, cardiac biomarkers
  • Glycemic control [ Time Frame: month 6 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
  • Glycemic control [ Time Frame: month 12 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
  • Insulin metabolism [ Time Frame: day 1 ]
    Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
  • Insulin metabolism [ Time Frame: month 3 ]
    Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
  • Insulin metabolism [ Time Frame: month 6 ]
    Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
  • Insulin metabolism [ Time Frame: month 12 ]
    Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
  • Cardiac function [ Time Frame: day 1 ]
    Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)
  • Cardiac function [ Time Frame: month 3 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)
  • Cardiac function [ Time Frame: month 6 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)
  • Cardiac function [ Time Frame: month 12 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)
  • Inflammation and oxidative stress [ Time Frame: day 1 ]
    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))
  • Inflammation and oxidative stress [ Time Frame: month 3 ]
    CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
  • Inflammation and oxidative stress [ Time Frame: month 6 ]
    CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)
  • Inflammation and oxidative stress [ Time Frame: month 12 ]
    CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
  • body composition [ Time Frame: day 1 ]
    body composition, measured using dual x-ray absorptiometry
  • body composition [ Time Frame: month 6 ]
    body composition, measured using dual x-ray absorptiometry
  • Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: day 1 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
  • Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 3 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
  • Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 6 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
  • Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 12 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
  • Glycemic control [ Time Frame: day 1 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
  • Glycemic control [ Time Frame: month 3 ]
    glycemic control, insulin sensitivity, inflammation, cardiac biomarkers
  • Glycemic control [ Time Frame: month 6 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
  • Glycemic control [ Time Frame: month 12 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
  • Insulin metabolism [ Time Frame: day 1 ]
    Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
  • Insulin metabolism [ Time Frame: month 3 ]
    Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
  • Insulin metabolism [ Time Frame: month 6 ]
    Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
  • Insulin metabolism [ Time Frame: month 12 ]
    Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
  • Cardiac function [ Time Frame: day 1 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)
  • Cardiac function [ Time Frame: month 3 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)
  • Cardiac function [ Time Frame: month 6 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)
  • Cardiac function [ Time Frame: month 12 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)
  • Inflammation and oxidative stress [ Time Frame: day 1 ]
    CRP levles, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
  • Inflammation and oxidative stress [ Time Frame: month 3 ]
    CRP levles, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
  • Inflammation and oxidative stress [ Time Frame: month 6 ]
    CRP levles, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
  • Inflammation and oxidative stress [ Time Frame: month 12 ]
    CRP levles, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
  • body composition [ Time Frame: day 1 ]
    body composition, measured using dual x-ray absorptiometry
  • body composition [ Time Frame: month 6 ]
    body composition, measured using dual x-ray absorptiometry
  • Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: day 1 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
  • Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 3 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
  • Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 6 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
  • Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 12 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Not Provided
Not Provided
 
Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Diabetic Cardiomyopathies
  • Type2 Diabetes
  • Other: high-intensity interval exercise training (HIIT)
    This program includes 12 weeks of exercise training and is divided in 3 phases (phase 1: week 1-2, phase 2: week 3-6, phase 3: week 7-12).
  • Other: moderate-intensity exercise training (MIT)
    the exercise training program consists of 3 endurance exercise sessions per week (for 6 months). During each exercise training session, walking and cycling exercise is performed, for a total duration of 45 min (including 5 min of warming-up and cooling-down, at 65% of VO2peak.
  • Active Comparator: traininggroup 1: HIIT
    high-intensity interval exercise training group (T2DM patients)
    Intervention: Other: high-intensity interval exercise training (HIIT)
  • Active Comparator: training group 2: MIT
    moderate-intensity exercise training group (T2DM patients)
    Intervention: Other: moderate-intensity exercise training (MIT)
  • No Intervention: control group
    Control group (T2DM patients)
  • No Intervention: healthy controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetes patients:

    • BMI > 20kg/m²
    • diagnosis of T2DM as stated in guidelines of ADA (American Diabetes Association)
    • non-insulin depend diabetes mellitus (NIDDM)
    • stable medication for at least 3 months
  • Healthy controls:

    • BMI > 20kg/m²
    • no diabetes

Exclusion Criteria:

  • iron deficiency anemia
  • participation in another clinical trial
  • heart diseases: CAD (coronary artery disease)

    , ischemia, valvular diseases, congenital heart diseases

  • neurological, pneumological, oncological, orthopedic disorders
  • diabetes complications: renal diseases, retinopathy
Sexes Eligible for Study: All
18 Years to 71 Years   (Adult, Older Adult)
Yes
Contact: Dominique Hansen, prof. dr. +32 11 29 21 26 dominique.hansen@uhasselt.be
Contact: Lisa Van Ryckeghem, drs. +32 11 26 93 70 lisa.vanryckeghem@uhasselt.be
Belgium
 
 
NCT03299790
HITDCM01
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Dominique Hansen, Hasselt University
Hasselt University
Jessa Hospital
Not Provided
Hasselt University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP