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

This study has been completed.
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
First received: October 25, 2010
Last updated: April 4, 2013
Last verified: April 2013

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 Intervention
Coronary Artery Disease
Diabetes Mellitus, Type 2
Behavioral: Exercise

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 137
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
12 months of exercise training
Behavioral: Exercise
12 months of exercise training
No Intervention: Control
Normal follow-up by primary physician


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01232608

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

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01232608     History of Changes
Other Study ID Numbers: 2010/1060-1 
Study First Received: October 25, 2010
Last Updated: April 4, 2013
Health Authority: Norway: Regional Ethics Commitee

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

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

ClinicalTrials.gov processed this record on May 26, 2016