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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01232608
First received: October 25, 2010
Last updated: April 4, 2013
Last verified: April 2013

October 25, 2010
April 4, 2013
June 2010
March 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01232608 on ClinicalTrials.gov Archive Site
  • 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
  • Dyslipidemia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Dyslipedemia 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
Not Provided
Not Provided
 
Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Diabetes Mellitus, Type 2
  • Atherosclerosis
Behavioral: Exercise
12 months of exercise training
  • Experimental: Exercise
    12 months of exercise training
    Intervention: Behavioral: Exercise
  • No Intervention: Control
    Normal follow-up by primary physician
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01232608
2010/1060-1
Yes
Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Ingebjørg Seljeflot, phd professor Oslo University Hospital Ullevaal
Oslo University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP