Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals With Insulin Resistance
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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 |
- 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 |
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| United States, Missouri | |
| Harry S. Truman Memorial VA Medical Center | |
| Columbia, Missouri, United States, 65201-5297 | |
| 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 May 16, 2013