Clinical trial NCT03299790: Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
Official title: Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Cardiomyopathies
Type2 Diabetes
Keywords: Type 2 diabetes
Diabetic cardiomyopathy
Cardiac function
Exercise echocardiography
Exercise training
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2017-10-03
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transthoracic echocardiography (TTE) during excercise
timeFrame: day 1
measure: Transthoracic echocardiography (TTE) during excercise
timeFrame: month 3
measure: Transthoracic echocardiography (TTE) during excercise
timeFrame: month 6
measure: Transthoracic echocardiography (TTE) during excercise
timeFrame: month 12
measure: Transthoracic echocardiography (TTE)
timeFrame: day 1
measure: Transthoracic echocardiography (TTE)
timeFrame: month 3
measure: Transthoracic echocardiography (TTE)
timeFrame: month 6
measure: Transthoracic echocardiography (TTE)
timeFrame: month 12
measure: ECG (Electrocardiogram) during excercise
timeFrame: month 3
measure: ECG (Electrocardiogram) during excercise
timeFrame: month 12
measure: ECG (Electrocardiogram)
timeFrame: month 3
measure: ECG (Electrocardiogram)
timeFrame: month 12
Secondary outcomes:
measure: Glycemic control
timeFrame: day 1
measure: Glycemic control
timeFrame: month 3
measure: Glycemic control
timeFrame: month 6
measure: Glycemic control
timeFrame: month 12
measure: Insulin metabolism
timeFrame: day 1
measure: Insulin metabolism
timeFrame: month 3
measure: Insulin metabolism
timeFrame: month 6
measure: Insulin metabolism
timeFrame: month 12
measure: Cardiac function
timeFrame: day 1
measure: Cardiac function
timeFrame: month 3
measure: Cardiac function
timeFrame: month 6
measure: Cardiac function
timeFrame: month 12
measure: Inflammation and oxidative stress
timeFrame: day 1
measure: Inflammation and oxidative stress
timeFrame: month 3
measure: Inflammation and oxidative stress
timeFrame: month 6
measure: Inflammation and oxidative stress
timeFrame: month 12
measure: body composition
timeFrame: day 1
measure: body composition
timeFrame: month 6
measure: Maximal oxygen uptake (ml/O2/kg/min)
timeFrame: day 1
measure: Maximal oxygen uptake (ml/O2/kg/min)
timeFrame: month 3
measure: Maximal oxygen uptake (ml/O2/kg/min)
timeFrame: month 6
measure: Maximal oxygen uptake (ml/O2/kg/min)
timeFrame: month 12
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.