- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00018239
Aging and Cellular Mechanism for Insulin Action After Exercise Training
January 20, 2009 updated by: US Department of Veterans Affairs
This study will determine whether the metabolic and cellular mechanisms contributing to improved insulin action after aerobic or resistive exercise are different in older, obese, insulin resistant veterans.
The hypothesis is that regular exercise, whether aerobic or resistive, will improve whole body insulin action, but the nature and magnitude of changes in skeletal muscle will differ between the two types of exercise.
Study Overview
Detailed Description
Veterans will be of comparable body composition and age, and randomly assigned to either aerobic or resistive exercise.
They will be instructed in a weight maintenance diet prior to beginning the exercise program, and maintain this diet throughout the study.
Metabolic testing will be performed at baseline and after 6 months of exercise training.
Testing will include measurement of body composition (anthropometry, dual-energy Xray absorptiometry, computed tomograph scan), maximal oxygen consumption, and muscle strength, glucose tolerance (oral glucose tolerance test), insulin sensitivity (euglycemic-hyperinsulinemic clamp), and muscle biopsies to examine skeletal muscle metabolic characteristics (fiber type distribution, capillary density, oxidative and glycolytic enzyme activities, and levels of key proteins important in insulin signaling and glucose transport).
Data will be analyzed using analysis of variance to determine differences between the two exercise groups, and multiple regression analysis to determine the primary adaptations that are associated with the improvements in whole body insulin action.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- VA Maryland Health Care System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Males between 50 years and 80 years
Overweight
Non-smoker
Sedentary (no regular exercise for one year)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Andrew P Goldberg, M.D.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1999
Primary Completion
December 7, 2022
Study Completion
September 1, 2002
Study Registration Dates
First Submitted
July 3, 2001
First Submitted That Met QC Criteria
July 4, 2001
First Posted (Estimate)
July 5, 2001
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
December 1, 2004
More Information
Terms related to this study
Other Study ID Numbers
- AGCG-001-99S
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.