Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Transthoracic echocardiography (TTE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 81 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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,...)
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,...)
ECG (Electrocardiogram) during excercise
Time Frame: month 12
ECG during excercise (an incremental exercise test on a cycle)
ECG (Electrocardiogram)
Time Frame: month 12
ECG in rest
Secondary Outcomes
- Glycemic control(month 12)
- Insulin metabolism(month 12)
- body composition(month 6)
- Maximal oxygen uptake (ml/O2/kg/min)(month 12)
- Cardiac function(month 12)
- Inflammation and oxidative stress(month 12)
Investigators
Dominique Hansen
prof. dr.
Hasselt University