Diabetic Cardiomyopathies, Type2 Diabetes
Conditions
Keywords
Type 2 diabetes, Diabetic cardiomyopathy, Cardiac function, Exercise echocardiography, Exercise training
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.
Interventions
OTHERhigh-intensity interval exercise training (HIIT)
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).
OTHERmoderate-intensity exercise training (MIT)
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.
Sponsors
Jessa Hospital
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transthoracic echocardiography (TTE) during excercise | 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,…) |
| Transthoracic echocardiography (TTE) | 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,…) |
| ECG (Electrocardiogram) during excercise | month 3 | ECG during excercise (an incremental exercise test on a cycle) |
| ECG (Electrocardiogram) | month 3 | ECG in rest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body composition | day 1 | body composition, measured using dual x-ray absorptiometry |
| Glycemic control | day 1 | glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers |
| Maximal oxygen uptake (ml/O2/kg/min) | day 1 | exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol |
| Insulin metabolism | day 1 | Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g) |
| Cardiac function | day 1 | Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels) |
| Inflammation and oxidative stress | 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)) |
Countries
Belgium
Outcome results
None listed