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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299790
• Other study ID #: HITDCM01
• Status: Completed
• Phase: N/A
• Start date: October 6, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 81 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetes Mellitus, Type 2
• Diabetic Cardiomyopathies
• Type2 Diabetes

Intervention

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).
• 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.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transthoracic echocardiography (TTE) during excercise	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,…)	day 1
Primary	Transthoracic echocardiography (TTE) during excercise	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,…)	month 3
Primary	Transthoracic echocardiography (TTE) during excercise	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,…)	month 6
Primary	Transthoracic echocardiography (TTE) during excercise	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,…)	month 12
Primary	Transthoracic echocardiography (TTE)	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,…)	day 1
Primary	Transthoracic echocardiography (TTE)	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,…)	month 3
Primary	Transthoracic echocardiography (TTE)	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,…)	month 6
Primary	Transthoracic echocardiography (TTE)	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,…)	month 12
Primary	ECG (Electrocardiogram) during excercise	ECG during excercise (an incremental exercise test on a cycle)	month 3
Primary	ECG (Electrocardiogram) during excercise	ECG during excercise (an incremental exercise test on a cycle)	month 12
Primary	ECG (Electrocardiogram)	ECG in rest	month 3
Primary	ECG (Electrocardiogram)	ECG in rest	month 12
Secondary	Glycemic control	glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers	day 1
Secondary	Glycemic control	glycemic control, insulin sensitivity, inflammation, cardiac biomarkers	month 3
Secondary	Glycemic control	glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers	month 6
Secondary	Glycemic control	glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers	month 12
Secondary	Insulin metabolism	Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)	day 1
Secondary	Insulin metabolism	Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)	month 3
Secondary	Insulin metabolism	Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)	month 6
Secondary	Insulin metabolism	Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)	month 12
Secondary	Cardiac function	Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)	day 1
Secondary	Cardiac function	Cardiac biomarkers (BNP levels, cardiac troponin levels)	month 3
Secondary	Cardiac function	Cardiac biomarkers (BNP levels, cardiac troponin levels)	month 6
Secondary	Cardiac function	Cardiac biomarkers (BNP levels, cardiac troponin levels)	month 12
Secondary	Inflammation and oxidative stress	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))	day 1
Secondary	Inflammation and oxidative stress	CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)	month 3
Secondary	Inflammation and oxidative stress	CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)	month 6
Secondary	Inflammation and oxidative stress	CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)	month 12
Secondary	body composition	body composition, measured using dual x-ray absorptiometry	day 1
Secondary	body composition	body composition, measured using dual x-ray absorptiometry	month 6
Secondary	Maximal oxygen uptake (ml/O2/kg/min)	exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol	day 1
Secondary	Maximal oxygen uptake (ml/O2/kg/min)	exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol	month 3
Secondary	Maximal oxygen uptake (ml/O2/kg/min)	exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol	month 6
Secondary	Maximal oxygen uptake (ml/O2/kg/min)	exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol	month 12