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NCT Number: NCT03299790

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.

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Key information

Conditions

Diabetic Cardiomyopathies Cardiomyopathies Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type2 Diabetes

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes patients:
  • BMI > 20kg/m²
  • diagnosis of T2DM as stated in guidelines of ADA (American Diabetes Association)
  • 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

Treatment and study plan

high-intensity interval exercise training (HIIT)

Other

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).

moderate-intensity exercise training (MIT)

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 3, 2017
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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