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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Diabetes Mellitus, Type 2; Atherosclerosis
• Interventions: Behavioral: Exercise

• Registration Number: NCT01232608
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	12 months of exercise training

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dyslipidemia	12 months	Dyslipidemia will be measured by total cholesterol, HDL, LDL, fasting triglycerides and free fatty acids
Visceral obesity	12 months	Visceral obesity will be measured by waist circumference

Trial Locations

Locations (1)

Oslo University Hospital, Ullevål; 🇳🇴 Oslo, Norway