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Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals With Insulin Resistance

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: August 4, 2009
Last updated: April 3, 2015
Last verified: April 2015
The overall aim of the project is to determine whether or not exercise influences cardiovascular or nervous responses to meal ingestion in individuals with insulin resistance or type 2 diabetes.

Condition Intervention
Insulin Resistance
Behavioral: Exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physical Inactivity and Insulin Resistance in Skeletal Muscle

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Insulin Sensitivity After 5-7 Days of Exercise [ Time Frame: baseline and 24h after 5-7 days of exercise ]
    Insulin sensitivity measured during an oral glucose tolerance test measured by the Matsuda Index. Matsuda insulin sensitivity index= 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during oral glucose tolerance test).

  • Blood Flow in Response to Oral Glucose Tolerance Tests [ Time Frame: pre and 24 hours post 5-7 days of exercise ]
    Blood flow response in the femoral artery measured by Doppler ultrasound during and oral glucose tolerance test. Data are represented as % change in blood flow during the oral glucose tolerance at 60 minutes vs. 0 minutes (prior to drinking the glucose)

Enrollment: 11
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
exercise - supervised exercise (treadmill walking or cycle ergometer use)
Behavioral: Exercise
daily exercise: supervised treadmill walking or cycle ergometry use

Detailed Description:
Participants will undergo a screening procedure, including telephone screening and physical examination, as well as determination of body composition and fitness. Participants will be asked to complete 5-10 days of supervised exercise training and will undergo testing to assess cardiovascular and metabolic responses to an oral glucose tolerance test, including muscle sympathetic nerve activity, blood flow, and circulating glucose and insulin concentrations at baseline and following training. In addition, day-to-day variations in blood glucose will also be monitored. The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose >/= 100 mg/dL
  • T2D: diagnosed by primary care physician
  • BMI: less than 43 kg/m2
  • Age: 30-65

Exclusion Criteria:

  • Smoking
  • Insulin use (other than once daily)
  • Underlying conditions that limit ability to exercise safely
  • Recent weight gain or loss (>5% of body weight in 3 months)
  • Physically active (>30 min aerobic exercise, 2 d/wk)
  • Recent (<3 mo) changes in medication use or dose
  • Uncontrolled T2D (HbA1c>10%)
  • Advanced retinopathy or neuropathy
  • Pregnancy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00954109

United States, Missouri
Harry S. Truman Memorial VA Medical Center
Columbia, Missouri, United States, 65201-5297
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: John Thyfault, PhD Harry S. Truman Memorial VA Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT00954109     History of Changes
Obsolete Identifiers: NCT00572676
Other Study ID Numbers: CDA-2-051-07S
Study First Received: August 4, 2009
Results First Received: January 8, 2015
Last Updated: April 3, 2015

Keywords provided by VA Office of Research and Development:
Insulin Resistance
Type 2 Diabetes

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017