Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy

Hasselt University

Status: Completed

Conditions: Type2 Diabetes; Diabetic Cardiomyopathies

Treatments: Other: moderate-intensity exercise training (MIT); Other: high-intensity interval exercise training (HIIT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03299790

HITDCM01

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 81 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 4 patient groups

training group 1: HIIT

Active Comparator group

Description:

high-intensity interval exercise training group (T2DM patients)

Treatment:

Other: high-intensity interval exercise training (HIIT)

training group 2: MIT

Active Comparator group

Description:

moderate-intensity exercise training group (T2DM patients)

Treatment:

Other: moderate-intensity exercise training (MIT)

Detraining period

No Intervention group

Description:

Follow-up: detraining of group 1 and 2 (T2DM patients)

Healthy controls

No Intervention group