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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01232608
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : April 5, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Mellitus, Type 2 Atherosclerosis Behavioral: Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
Study Start Date : June 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: Exercise
12 months of exercise training
Behavioral: Exercise
12 months of exercise training

No Intervention: Control
Normal follow-up by primary physician

Primary Outcome Measures :
  1. Glucometabolic state [ Time Frame: 12 months ]
    Glucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose

  2. Atherosclerosis [ Time Frame: 12 months ]

    Atherosclerosis will be assessed by measurements of:

    • Carotid intima-media thickness (IMT)
    • Biomarkers of inflammation, haemostasis and endothelial function

Secondary Outcome Measures :
  1. Dyslipidemia [ Time Frame: 12 months ]
    Dyslipidemia will be measured by total cholesterol, HDL, LDL, fasting triglycerides and free fatty acids

  2. Visceral obesity [ Time Frame: 12 months ]
    Visceral obesity will be measured by waist circumference

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01232608

Oslo University Hospital, Ullevål
Oslo, Norway, NO-0424
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Ingebjørg Seljeflot, phd professor Oslo University Hospital

Responsible Party: Oslo University Hospital Identifier: NCT01232608     History of Changes
Other Study ID Numbers: 2010/1060-1
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Oslo University Hospital:
Coronary Artery Disease
Diabetes Mellitus, type 2
Carotid Atherosclerotic Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases