Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes (EXCADI)
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.
Coronary Artery Disease
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes|
- Glucometabolic state [ Time Frame: 12 months ] [ Designated as safety issue: No ]Glucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose
- Atherosclerosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Atherosclerosis will be assessed by measurements of:
- Carotid intima-media thickness (IMT)
- Biomarkers of inflammation, haemostasis and endothelial function
- Dyslipidemia [ Time Frame: 12 months ] [ Designated as safety issue: No ]Dyslipidemia will be measured by total cholesterol, HDL, LDL, fasting triglycerides and free fatty acids
- Visceral obesity [ Time Frame: 12 months ] [ Designated as safety issue: No ]Visceral obesity will be measured by waist circumference
|Study Start Date:||June 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
12 months of exercise training
12 months of exercise training
No Intervention: Control
Normal follow-up by primary physician
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232608
|Oslo University Hospital, Ullevål|
|Oslo, Norway, NO-0424|
|Principal Investigator:||Ingebjørg Seljeflot, phd professor||Oslo University Hospital Ullevaal|