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

Coronary Artery Disease Clinical Trial

— EXCADI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232608
• Other study ID #: 2010/1060-1
• Status: Completed
• Phase: N/A
• First received: October 25, 2010
• Last updated: April 4, 2013
• Start date: June 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Exercise
12 months of exercise training

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucometabolic state	Glucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose	12 months	No
Primary	Atherosclerosis	Atherosclerosis will be assessed by measurements of: Carotid intima-media thickness (IMT); Biomarkers of inflammation, haemostasis and endothelial function	12 months	No
Secondary	Dyslipidemia	Dyslipidemia will be measured by total cholesterol, HDL, LDL, fasting triglycerides and free fatty acids	12 months	No
Secondary	Visceral obesity	Visceral obesity will be measured by waist circumference	12 months	No