Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
NCT ID: NCT01232608
Last Updated: 2013-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2010-06-30
2013-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise
12 months of exercise training
Exercise
12 months of exercise training
Control
Normal follow-up by primary physician
No interventions assigned to this group
Interventions
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Exercise
12 months of exercise training
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ingebjørg Seljeflot, phd professor
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital, Ullevål
Oslo, , Norway
Countries
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References
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Zaidi H, Byrkjeland R, Njerve IU, Akra S, Solheim S, Arnesen H, Seljeflot I, Opstad TB. Adiponectin in relation to exercise and physical performance in patients with type 2 diabetes and coronary artery disease. Adipocyte. 2021 Dec;10(1):612-620. doi: 10.1080/21623945.2021.1996699.
Aune SK, Byrkjeland R, Solheim S, Arnesen H, Troseid M, Awoyemi A, Seljeflot I, Helseth R. Gut related inflammation and cardiorespiratory fitness in patients with CAD and type 2 diabetes: a sub-study of a randomized controlled trial on exercise training. Diabetol Metab Syndr. 2021 Apr 1;13(1):36. doi: 10.1186/s13098-021-00655-2.
Zaidi H, Byrkjeland R, Njerve IU, Akra S, Solheim S, Arnesen H, Seljeflot I, Opstad TB. Effects of exercise training on markers of adipose tissue remodeling in patients with coronary artery disease and type 2 diabetes mellitus: sub study of the randomized controlled EXCADI trial. Diabetol Metab Syndr. 2019 Dec 19;11:109. doi: 10.1186/s13098-019-0508-9. eCollection 2019.
Other Identifiers
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2010/1060-1
Identifier Type: -
Identifier Source: org_study_id
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