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Clinical Trials/NCT03299790
NCT03299790
Completed
N/A

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

Hasselt University1 site in 1 country53 target enrollmentOctober 6, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Cardiomyopathies
Sponsor
Hasselt University
Enrollment
53
Locations
1
Primary Endpoint
Transthoracic echocardiography (TTE)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 6, 2017
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Dominique Hansen

prof. dr.

Hasselt University

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

Outcomes

Primary Outcomes

Transthoracic echocardiography (TTE)

Time Frame: 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

Time Frame: 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

Time Frame: month 12

ECG during excercise (an incremental exercise test on a cycle)

ECG (Electrocardiogram)

Time Frame: month 12

ECG in rest

Secondary Outcomes

  • Glycemic control(month 12)
  • Insulin metabolism(month 12)
  • body composition(month 6)
  • Maximal oxygen uptake (ml/O2/kg/min)(month 12)
  • Cardiac function(month 12)
  • Inflammation and oxidative stress(month 12)

Study Sites (1)

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