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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:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Diabetic Cardiomyopathies Type2 Diabetes Other: high-intensity interval exercise training (HIIT) Other: moderate-intensity exercise training (MIT)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
Anticipated Study Start Date : October 6, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: traininggroup 1: HIIT
high-intensity interval exercise training group (T2DM patients)
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).
Active Comparator: training group 2: MIT
moderate-intensity exercise training group (T2DM patients)
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.
No Intervention: control group
Control group (T2DM patients)
No Intervention: healthy controls


Outcome Measures

Primary Outcome Measures :
  1. 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,…)

  2. 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,…)

  3. 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,…)

  4. 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,…)

  5. 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,…)

  6. 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,…)

  7. 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,…)

  8. 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,…)

  9. ECG (Electrocardiogram) during excercise [ Time Frame: month 3 ]
    ECG during excercise (an incremental exercise test on a cycle)

  10. ECG (Electrocardiogram) during excercise [ Time Frame: month 12 ]
    ECG during excercise (an incremental exercise test on a cycle)

  11. ECG (Electrocardiogram) [ Time Frame: month 3 ]
    ECG in rest

  12. ECG (Electrocardiogram) [ Time Frame: month 12 ]
    ECG in rest


Secondary Outcome Measures :
  1. Glycemic control [ Time Frame: day 1 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers

  2. Glycemic control [ Time Frame: month 3 ]
    glycemic control, insulin sensitivity, inflammation, cardiac biomarkers

  3. Glycemic control [ Time Frame: month 6 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers

  4. Glycemic control [ Time Frame: month 12 ]
    glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. Cardiac function [ Time Frame: day 1 ]
    Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)

  10. Cardiac function [ Time Frame: month 3 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)

  11. Cardiac function [ Time Frame: month 6 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)

  12. Cardiac function [ Time Frame: month 12 ]
    Cardiac biomarkers (BNP levels, cardiac troponin levels)

  13. 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))

  14. Inflammation and oxidative stress [ Time Frame: month 3 ]
    CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)

  15. Inflammation and oxidative stress [ Time Frame: month 6 ]
    CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)

  16. Inflammation and oxidative stress [ Time Frame: month 12 ]
    CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)

  17. body composition [ Time Frame: day 1 ]
    body composition, measured using dual x-ray absorptiometry

  18. body composition [ Time Frame: month 6 ]
    body composition, measured using dual x-ray absorptiometry

  19. Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: day 1 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol

  20. Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 3 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol

  21. Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 6 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol

  22. Maximal oxygen uptake (ml/O2/kg/min) [ Time Frame: month 12 ]
    exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299790


Contacts
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

Locations
Belgium
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Dominque 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   
Sponsors and Collaborators
Hasselt University
Jessa Hospital
More Information

Responsible Party: Dominique Hansen, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT03299790     History of Changes
Other Study ID Numbers: HITDCM01
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dominique Hansen, Hasselt University:
Type 2 diabetes
Diabetic cardiomyopathy
Cardiac function
Exercise echocardiography
Exercise training

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Cardiomyopathies
Diabetic Cardiomyopathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Diabetes Complications