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Sponsor study identifier
interventional
53
1 country
1
Study Start
October 6, 2017
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
September 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 12, 2017
Actual (reported)October 3, 2017
Actual (reported)October 6, 2017
Actual (reported)December 31, 2019
Actual (reported)September 30, 2020
Actual (reported)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,…)
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,…)
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,…)
month 6
Glycemic control
day 1
Glycemic control
month 3
Glycemic control
month 6
Glycemic control
month 12
Insulin metabolism
day 1
high-intensity interval exercise training group (T2DM patients)
moderate-intensity exercise training group (T2DM patients)
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).
Jessa Ziekenhuis
Hasselt, 3500, Belgium
Van Ryckeghem L, Keytsman C, De Brandt J, Verboven K, Verbaanderd E, Marinus N, Franssen WMA, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Impact of continuous vs. interval training on oxygen extraction and cardiac function during exercise in type 2 diabetes mellitus. Eur J Appl Physiol. 2022 Apr;122(4):875-887. doi: 10.1007/s00421-022-04884-9. Epub 2022 Jan 17.
Van Ryckeghem L, Keytsman C, Verboven K, Verbaanderd E, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Exercise capacity is related to attenuated responses in oxygen extraction and left ventricular longitudinal strain in asymptomatic type 2 diabetes patients. Eur J Prev Cardiol. 2022 Jan 11;28(16):1756-1766. doi: 10.1093/eurjpc/zwaa007.
53 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2017
First Posted
October 3, 2017
Study Start
October 6, 2017
Actual (reported)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,…)
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,…)
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,…)
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,…)
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,…)
month 12
ECG (Electrocardiogram) during excercise
ECG during excercise (an incremental exercise test on a cycle)
month 3
ECG (Electrocardiogram) during excercise
ECG during excercise (an incremental exercise test on a cycle)
month 12
ECG (Electrocardiogram)
ECG in rest
month 3
ECG (Electrocardiogram)
ECG in rest
month 12
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.
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Van Ryckeghem L, Keytsman C, Verbaanderd E, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Asymptomatic type 2 diabetes mellitus display a reduced myocardial deformation but adequate response during exercise. Eur J Appl Physiol. 2021 Mar;121(3):929-940. doi: 10.1007/s00421-020-04557-5. Epub 2021 Jan 8.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
September 30, 2020
Actual (reported)Last Updated
December 10, 2020
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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