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
  Purpose

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
Atherosclerosis
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232608

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

No publications provided

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

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

ClinicalTrials.gov processed this record on August 21, 2014