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

This study is not yet open for participant recruitment.

Verified by Department of Veterans Affairs, August 2009

First Received: August 4, 2009 Last Updated: August 13, 2009 History of Changes

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00954109

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:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Physical Inactivity and Insulin Resistance in Skeletal Muscle

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

Drug Information available for: Insulin

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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

Department of Veterans Affairs

Investigators

Principal Investigator:

John Thyfault, PhD

Harry S. Truman Memorial VA Medical Center

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Thyfault, John - Principal Investigator )
Study ID Numbers:	CDA-2-051-07S
Study First Received:	August 4, 2009
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00954109 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Insulin Resistance
Type 2 Diabetes

Study placed in the following topic categories:

Hyperinsulinism
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hyperinsulinism
Metabolic Diseases
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009