Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
Primary Purpose
Diabetic Cardiomyopathies, Type2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
high-intensity interval exercise training (HIIT)
moderate-intensity exercise training (MIT)
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetic Cardiomyopathies focused on measuring Type 2 diabetes, Diabetic cardiomyopathy, Cardiac function, Exercise echocardiography, Exercise training
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
Sites / Locations
- Jessa Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
No Intervention
No Intervention
Arm Label
training group 1: HIIT
training group 2: MIT
Detraining period
Healthy controls
Arm Description
high-intensity interval exercise training group (T2DM patients)
moderate-intensity exercise training group (T2DM patients)
Follow-up: detraining of group 1 and 2 (T2DM patients)
Outcomes
Primary Outcome Measures
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,…)
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,…)
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,…)
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,…)
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,…)
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,…)
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,…)
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,…)
ECG (Electrocardiogram) during excercise
ECG during excercise (an incremental exercise test on a cycle)
ECG (Electrocardiogram) during excercise
ECG during excercise (an incremental exercise test on a cycle)
ECG (Electrocardiogram)
ECG in rest
ECG (Electrocardiogram)
ECG in rest
Secondary Outcome Measures
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Glycemic control
glycemic control, insulin sensitivity, inflammation, cardiac biomarkers
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Cardiac function
Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
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))
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
body composition
body composition, measured using dual x-ray absorptiometry
body composition
body composition, measured using dual x-ray absorptiometry
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Full Information
NCT ID
NCT03299790
First Posted
September 12, 2017
Last Updated
December 9, 2020
Sponsor
Hasselt University
Collaborators
Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03299790
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Cardiomyopathies, Type2 Diabetes
Keywords
Type 2 diabetes, Diabetic cardiomyopathy, Cardiac function, Exercise echocardiography, Exercise training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
training group 1: HIIT
Arm Type
Active Comparator
Arm Description
high-intensity interval exercise training group (T2DM patients)
Arm Title
training group 2: MIT
Arm Type
Active Comparator
Arm Description
moderate-intensity exercise training group (T2DM patients)
Arm Title
Detraining period
Arm Type
No Intervention
Arm Description
Follow-up: detraining of group 1 and 2 (T2DM patients)
Arm Title
Healthy controls
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
high-intensity interval exercise training (HIIT)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
moderate-intensity exercise training (MIT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transthoracic echocardiography (TTE) during excercise
Description
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,…)
Time Frame
day 1
Title
Transthoracic echocardiography (TTE) during excercise
Description
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,…)
Time Frame
month 3
Title
Transthoracic echocardiography (TTE) during excercise
Description
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,…)
Time Frame
month 6
Title
Transthoracic echocardiography (TTE) during excercise
Description
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,…)
Time Frame
month 12
Title
Transthoracic echocardiography (TTE)
Description
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,…)
Time Frame
day 1
Title
Transthoracic echocardiography (TTE)
Description
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,…)
Time Frame
month 3
Title
Transthoracic echocardiography (TTE)
Description
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,…)
Time Frame
month 6
Title
Transthoracic echocardiography (TTE)
Description
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,…)
Time Frame
month 12
Title
ECG (Electrocardiogram) during excercise
Description
ECG during excercise (an incremental exercise test on a cycle)
Time Frame
month 3
Title
ECG (Electrocardiogram) during excercise
Description
ECG during excercise (an incremental exercise test on a cycle)
Time Frame
month 12
Title
ECG (Electrocardiogram)
Description
ECG in rest
Time Frame
month 3
Title
ECG (Electrocardiogram)
Description
ECG in rest
Time Frame
month 12
Secondary Outcome Measure Information:
Title
Glycemic control
Description
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Time Frame
day 1
Title
Glycemic control
Description
glycemic control, insulin sensitivity, inflammation, cardiac biomarkers
Time Frame
month 3
Title
Glycemic control
Description
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Time Frame
month 6
Title
Glycemic control
Description
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Time Frame
month 12
Title
Insulin metabolism
Description
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Time Frame
day 1
Title
Insulin metabolism
Description
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Time Frame
month 3
Title
Insulin metabolism
Description
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Time Frame
month 6
Title
Insulin metabolism
Description
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Time Frame
month 12
Title
Cardiac function
Description
Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)
Time Frame
day 1
Title
Cardiac function
Description
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Time Frame
month 3
Title
Cardiac function
Description
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Time Frame
month 6
Title
Cardiac function
Description
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Time Frame
month 12
Title
Inflammation and oxidative stress
Description
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))
Time Frame
day 1
Title
Inflammation and oxidative stress
Description
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
Time Frame
month 3
Title
Inflammation and oxidative stress
Description
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)
Time Frame
month 6
Title
Inflammation and oxidative stress
Description
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
Time Frame
month 12
Title
body composition
Description
body composition, measured using dual x-ray absorptiometry
Time Frame
day 1
Title
body composition
Description
body composition, measured using dual x-ray absorptiometry
Time Frame
month 6
Title
Maximal oxygen uptake (ml/O2/kg/min)
Description
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Time Frame
day 1
Title
Maximal oxygen uptake (ml/O2/kg/min)
Description
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Time Frame
month 3
Title
Maximal oxygen uptake (ml/O2/kg/min)
Description
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Time Frame
month 6
Title
Maximal oxygen uptake (ml/O2/kg/min)
Description
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Time Frame
month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
35038022
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.
Results Reference
derived
PubMed Identifier
33623980
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.
Results Reference
derived
PubMed Identifier
33417036
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.
Results Reference
derived
Learn more about this trial
Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
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