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Exercise Training, Insulin Resistance and Coronary Artery Disease

This study has been completed.
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Canadian Diabetes Association
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00412815
First received: December 14, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

The purpose of this study was to determine the effects of exercise training on insulin resistance in subjects with coronary artery disease independent of changes in weight, diet, or the effect of an acute bout of exercise. We hypothesized that subjects with CAD and high normal or impaired glucose tolerance performing 12 weeks of aerobic exercise training while on a non weight-reducing diet, would have a greater decrease in insulin resistance than controls measured at 72 hours following their last bout of exercise.


Condition Intervention Phase
Coronary Artery Disease
Glucose Intolerance
 Behavioral: Exercise training
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: The Effects of Exercise Training on Insulin Resistance in Patients With Coronary Artery Disease and Insulin Resistance, the Exercise, Coronary Artery Disease and Insulin Resistance (EXCADIR) Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Insulin sensitivity

Secondary Outcome Measures:
  • Exercise capacity

Estimated Enrollment: 60
Study Start Date: July 1997
Estimated Study Completion Date: January 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women over 18 years of age
  • fasting plasma glucose concentration 5.4-7.7 mmol/L
  • confirmed CAD (diagnosed on the basis of a previous myocardial perfusion study or cardiac catheterization, or a history of a myocardial infarction or coronary artery angioplasty or coronary artery bypass surgery).

Exclusion Criteria:

  • known type 1 or 2 diabetes
  • clinical heart failure
  • uncorrected significant valvular or congenital heart disease
  • significant obstructive pulmonary disease (forced expiratory volume in 1 sec / forced vital capacity < 0.5)
  • uncontrolled hypertension (blood pressure > 220 / 120 mm Hg)
  • participation in a regular exercise program within the preceding three months
  • inability to perform exercise training, atrial fibrillation
  • a permanent pacemaker
  • regularly used corticosteroid
  • recent (< 3 months) myocardial infarction, unstable angina, coronary artery bypass graft surgery, or coronary artery angioplasty
  • run-in phase fasting blood glucose was < 5.4 mmol/L or > 11.1 mmol/L at 2 hours following the 75 gram oral glucose load.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412815

Locations
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8L2X2
Sponsors and Collaborators
Lawson Health Research Institute
Hamilton Health Sciences Corporation
Canadian Diabetes Association
Investigators
Principal Investigator: Robert S McKelvie, MD McMaster Univesrity
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00412815     History of Changes
Other Study ID Numbers: R-99-004
Study First Received: December 14, 2006
Last Updated: December 14, 2006
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
insulin sensitivity
coronary artery disease
exercise training

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Insulin Resistance
Glucose Intolerance
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013