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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00954109
First received: August 4, 2009
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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: Endpoint Classification: Efficacy Study
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 Department of Veterans Affairs:

Primary Outcome Measures:
  • postprandial metabolic, vascular or autonomic nervous system responses [ Time Frame: baseline and 24h after 5-10 days of exercise ] [ Designated as safety issue: No ]

Enrollment: 6
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: Arm 1
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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00954109

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00954109     History of Changes
Obsolete Identifiers: NCT00572676
Other Study ID Numbers: CDA-2-051-07S
Study First Received: August 4, 2009
Last Updated: July 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Insulin Resistance
Type 2 Diabetes

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014