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OpenTrials
Completed

NCT Number: NCT01232608

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

12 months of exercise training

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: EXCADI

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2010
Registry last updated
Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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