Exercise Training, Insulin Resistance and Coronary Artery Disease

NCT00412815 | Completed Phase 3

• 1 other identifier: R-99-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Glucose Intolerance

Keywords

insulin sensitivity; coronary artery disease; exercise training

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

Secondary Outcomes (1)

• Exercise capacity

Interventions

Exercise training BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Hamilton Health Sciences Corporation: collaborator
• Canadian Diabetes Association: collaborator

Study Sites (1)

Hamilton Health Sciences Centre

Hamilton, Ontario, L8L2X2, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease; Glucose Intolerance; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Robert S McKelvie, MD

  McMaster Univesrity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 18, 2006
• Study Start: November 25, 1998
• Primary Completion: June 9, 2000
• Study Completion: June 9, 2000
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)