Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes

Study Overview
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Brief Summary
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Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular disease, and people with type 2 diabetes have a two- to four-fold increased risk for cardiovascular morbidity and mortality. Physical activity is a well established therapeutic modality for type 2 diabetes. In patients with coronary artery disease (CAD), several clinical trials have shown reduced mortality and reduced progression of atherosclerosis with lifestyle intervention including physical activity. But few studies have investigated the effect of physical training in patients suffering from both diseases. The aim of this study is to investigate the effect of one year of organized physical exercise in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and progression of atherosclerosis. The project is a randomized, controlled, open study on physical exercise. 136 patients will be randomized at inclusion to a physical exercise group or a control group, the latter with normal follow-up and not discouraged form physical activity. The intervention period will be 12 months, and the physical training program will be developed and conducted in collaboration with Norwegian School of Sport Sciences. The inclusion of patients started summer 2010, the exercise program begins in September 2010 and the practical issues of the study is planned to end during spring 2012. The main hypothesis is that physical exercise improves the glucometabolic state and reduces progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes, and secondary that physical exercise induces favourable changes in cardiovascular risk factors, use of medication, and co-morbidity associated with diabetes.

Official Title
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Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes

Conditions
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Coronary Artery Disease, Diabetes Mellitus, Type 2, Atherosclerosis

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: coronary artery disease type 2 diabetes Exclusion Criteria: serious diabetic retinopathy, nephropathy and/ or neuropathy other serious diseases like cancer, stroke or MI last three months, unstable angina, decompensated heart failure, serious ventricular arrhythmia, aortic aneurism, serious valvular heart disease, chronic obstructive pulmonary disease GOLD classification IV, deep venous/ pulmonary embolism, ongoing infections, serious musculoskeletal disorders. other serious limitations to physical exercise pathological exercise stress test warranting further cardiovascular examination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>12 months of exercise training | Behavioral: Exercise<br>* 12 months of exercise training<br>|
| No Intervention: Control<br>Normal follow-up by primary physician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucometabolic state | Glucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose | 12 months | 
| Atherosclerosis | Atherosclerosis will be assessed by measurements of: Carotid intima-media thickness (IMT) Biomarkers of inflammation, haemostasis and endothelial function | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyslipidemia | Dyslipidemia will be measured by total cholesterol, HDL, LDL, fasting triglycerides and free fatty acids | 12 months | 
| Visceral obesity | Visceral obesity will be measured by waist circumference | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Atherosclerosis., Diabetes Mellitus, type 2, Exercise, HbA1c, Carotid Atherosclerotic Disease, Inflammation