An interventional study of high-intensity interval exercise training (HIIT) and moderate-intensity exercise training (MIT) in Diabetic Cardiomyopathies and Type2 Diabetes, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years to 81 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Hasselt University · Not applicable, Interventional, and Supportive care
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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.
30 studies on the registry are indexed under Diabetic Cardiomyopathies; 9 are open to participants now.
This study's enrollment of 53 is below the median of 81 across 15 interventional studies indexed under Diabetic Cardiomyopathies.
Browse Diabetic Cardiomyopathies studies →Hasselt University is the lead sponsor of 204 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
type 2 diabetes patients:
Healthy controls:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
high-intensity interval exercise training group (T2DM patients)
Other: high-intensity interval exercise training (HIIT)
moderate-intensity exercise training group (T2DM patients)
Other: moderate-intensity exercise training (MIT)
Follow-up: detraining of group 1 and 2 (T2DM patients)
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).
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.
Transthoracic echocardiography (TTE) during excercise
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,...)
Time frame: day 1
Transthoracic echocardiography (TTE) during excercise
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,...)
Time frame: month 3
Transthoracic echocardiography (TTE) during excercise
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,...)
Time frame: month 6
Transthoracic echocardiography (TTE) during excercise
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,...)
Time frame: month 12
Transthoracic echocardiography (TTE)
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,...)
Time frame: day 1
Transthoracic echocardiography (TTE)
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,...)
Time frame: month 3
Transthoracic echocardiography (TTE)
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,...)
Time frame: month 6
Transthoracic echocardiography (TTE)
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,...)
Time frame: month 12
ECG (Electrocardiogram) during excercise
ECG during excercise (an incremental exercise test on a cycle)
Time frame: month 3
ECG (Electrocardiogram) during excercise
ECG during excercise (an incremental exercise test on a cycle)
Time frame: month 12
ECG (Electrocardiogram)
ECG in rest
Time frame: month 3
ECG (Electrocardiogram)
ECG in rest
Time frame: month 12
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Time frame: day 1
Glycemic control
glycemic control, insulin sensitivity, inflammation, cardiac biomarkers
Time frame: month 3
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Time frame: month 6
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Time frame: month 12
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Time frame: day 1
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Time frame: month 3
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Time frame: month 6
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Time frame: month 12
Cardiac function
Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)
Time frame: day 1
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Time frame: month 3
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Time frame: month 6
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Time frame: month 12
Inflammation and oxidative stress
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))
Time frame: day 1
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
Time frame: month 3
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)
Time frame: month 6
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
Time frame: month 12
body composition
body composition, measured using dual x-ray absorptiometry
Time frame: day 1
body composition
body composition, measured using dual x-ray absorptiometry
Time frame: month 6
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Time frame: day 1
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Time frame: month 3
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Time frame: month 6
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Time frame: month 12
Ran from Oct 2017 to primary completion in Dec 2019, 26 months.
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