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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
12 months of exercise training
Oslo University Hospital, Ullevål
Oslo, Norway
Glucometabolic state
Glucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose
Time frame: 12 months
Atherosclerosis
Atherosclerosis will be assessed by measurements of: * Carotid intima-media thickness (IMT) * Biomarkers of inflammation, haemostasis and endothelial function
Time frame: 12 months
Dyslipidemia
Dyslipidemia will be measured by total cholesterol, HDL, LDL, fasting triglycerides and free fatty acids
Time frame: 12 months
Visceral obesity
Visceral obesity will be measured by waist circumference
Time frame: 12 months
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