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

Not Applicable

Completed

• Conditions: Type2 Diabetes; Diabetic Cardiomyopathies
• Interventions: Other: high-intensity interval exercise training (HIIT); Other: moderate-intensity exercise training (MIT)

• Registration Number: NCT03299790
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Study Start: 2017-10-06
• Primary Completion: 2019-12-31
• Study Completion: 2020-09-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
training group 1: HIIT	high-intensity interval exercise training (HIIT)	high-intensity interval exercise training group (T2DM patients)
training group 2: MIT	moderate-intensity exercise training (MIT)	moderate-intensity exercise training group (T2DM patients)

Primary Outcome Measures

Name	Time	Method
Transthoracic echocardiography (TTE)	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	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	month 12	ECG during excercise (an incremental exercise test on a cycle)
ECG (Electrocardiogram)	month 12	ECG in rest

Secondary Outcome Measures

Name	Time	Method
Glycemic control	month 12	glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Insulin metabolism	month 12	Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
body composition	month 6	body composition, measured using dual x-ray absorptiometry
Maximal oxygen uptake (ml/O2/kg/min)	month 12	exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Cardiac function	month 12	Cardiac biomarkers (BNP levels, cardiac troponin levels)
Inflammation and oxidative stress	month 12	CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium