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

Sponsor

Hasselt University (Other)

Overall Status

Completed

CT.gov ID

NCT03299790

Collaborator

Jessa Hospital (Other)

Enrollment

Location

Arms

35.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Cardiomyopathies Type2 Diabetes	Other: high-intensity interval exercise training (HIIT) Other: moderate-intensity exercise training (MIT)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 6, 2017

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: training group 1: HIIT high-intensity interval exercise training group (T2DM patients)	Other: high-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).
Active Comparator: training group 2: MIT moderate-intensity exercise training group (T2DM patients)	Other: moderate-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.
No Intervention: Detraining period Follow-up: detraining of group 1 and 2 (T2DM patients)
No Intervention: Healthy controls

Outcome Measures

Primary Outcome Measures

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) during excercise [month 3]
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) during excercise [month 6]
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) 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,…)
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,…)
Transthoracic echocardiography (TTE) [month 3]
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) [month 6]
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) [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,…)
ECG (Electrocardiogram) during excercise [month 3]
ECG during excercise (an incremental exercise test on a cycle)
ECG (Electrocardiogram) during excercise [month 12]
ECG during excercise (an incremental exercise test on a cycle)
ECG (Electrocardiogram) [month 3]
ECG in rest
ECG (Electrocardiogram) [month 12]
ECG in rest

Secondary Outcome Measures

Glycemic control [day 1]
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Glycemic control [month 3]
glycemic control, insulin sensitivity, inflammation, cardiac biomarkers
Glycemic control [month 6]
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Glycemic control [month 12]
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
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)
Insulin metabolism [month 3]
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Insulin metabolism [month 6]
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
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)
Cardiac function [day 1]
Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)
Cardiac function [month 3]
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Cardiac function [month 6]
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Cardiac function [month 12]
Cardiac biomarkers (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))
Inflammation and oxidative stress [month 3]
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
Inflammation and oxidative stress [month 6]
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)
Inflammation and oxidative stress [month 12]
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
body composition [day 1]
body composition, measured using dual x-ray absorptiometry
body composition [month 6]
body composition, measured using dual x-ray absorptiometry
Maximal oxygen uptake (ml/O2/kg/min) [day 1]
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Maximal oxygen uptake (ml/O2/kg/min) [month 3]
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Maximal oxygen uptake (ml/O2/kg/min) [month 6]
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Maximal oxygen uptake (ml/O2/kg/min) [month 12]
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 81 Years

Sexes Eligible for Study:

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