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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01232608
Acronym
EXCADI
Enrollment
137
Registered
2010-11-02
Start date
2010-06-30
Completion date
2013-03-31
Last updated
2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Coronary Artery Disease, Diabetes Mellitus, Type 2

Keywords

Coronary Artery Disease, Atherosclerosis., Diabetes Mellitus, type 2, Exercise, HbA1c, Carotid Atherosclerotic Disease, Inflammation

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.

Interventions

BEHAVIORALExercise

12 months of exercise training

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Glucometabolic state12 monthsGlucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose
Atherosclerosis12 monthsAtherosclerosis will be assessed by measurements of: * Carotid intima-media thickness (IMT) * Biomarkers of inflammation, haemostasis and endothelial function

Secondary

MeasureTime frameDescription
Dyslipidemia12 monthsDyslipidemia will be measured by total cholesterol, HDL, LDL, fasting triglycerides and free fatty acids
Visceral obesity12 monthsVisceral obesity will be measured by waist circumference

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026