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Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by University of Virginia.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350064
First Posted: July 10, 2006
Last Update Posted: August 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
University of Virginia
  Purpose
The purpose of this study is to determine if sixteen weeks of high intensity physical training is more effective than sixteen weeks of low intensity physical training in reducing abdominal fat and lowering risk factors associated with the metabolic syndrome. Another aim of this study is to determine if high intensity physical training improves cognitive function.

Condition Intervention
Metabolic Syndrome Behavioral: Exercise Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Change in Abdominal Visceral Fat [ Time Frame: before and after 16 weeks ]

Secondary Outcome Measures:
  • VO2peak [ Time Frame: before and after 16 weeks ]
  • % Body Fat [ Time Frame: before and after 16 weeks ]
  • Insulin [ Time Frame: before and after 16 weeks ]
  • FFA [ Time Frame: before and after 16 weeks ]
  • Glucose [ Time Frame: before and after 16 weeks ]
  • Hba1c [ Time Frame: before and after 16 weeks ]
  • Cholesterol [ Time Frame: before and after 16 weeks ]
  • CRP [ Time Frame: before and after 16 weeks ]
  • IL6 [ Time Frame: before and after 16 weeks ]
  • TNF [ Time Frame: before and after 16 weeks ]
  • Homocysteine [ Time Frame: before and after 16 weeks ]
  • Adiponectin [ Time Frame: before and after 16 weeks ]
  • Adhesion Molecules [ Time Frame: before and after 16 weeks ]
  • Endothelial Function [ Time Frame: before and after 16 weeks ]

Estimated Enrollment: 165
Study Start Date: April 2004
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Exercise Training
    16 weeks of aerobic exercise training at two different intensities
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers must have meet the definition of the metabolic syndrome (based on IDF consensus statement).
  • Screening biochemical tests of liver, kidney, hematologic, metabolic (below) and thyroid function must be normal.
  • The volunteer must be willing to:

    1. visit the outpatient GCRC or clinic once monthly for 16 weeks of intervention,
    2. participate in supervised exercise training (if assigned) and
    3. enter the inpatient GCRC for 2-3 days of more intensive studies at baseline and after 16 weeks of intervention. The subject must provide voluntary and fully informed written consent.

Exclusion Criteria:

  • Type 1 diabetes,
  • drug or alcohol abuse,
  • psychosis,
  • severe or untreated depression,
  • dementia, polycythemia (hematocrit > 55%),
  • clinically symptomatic coronary artery,
  • pulmonary or orthopedic disease (which would disallow exercise training),
  • history of vascular or peripheral nerve trauma,
  • lymph node dissection,
  • anemia, uncontrolled hypertension (> 160/105 untreated or > 145/95 treated),
  • allergic to octafluoropropane, or nitroglycerine,
  • weight loss or gain of 2 kg or more within the preceding 10 days,
  • investigational drug use within five biological half-lives,
  • treatment with ACE inhibitors or ARBs, thiazolindiones,
  • 1st or 2nd generation anti-psychotics insulin, or Viagra,
  • unwillingness to provide written informed voluntary consent,
  • pregnant, breast feeding or use hormonal birth control.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350064


Locations
United States, Virginia
University of Virginia General Clinical Research Center
Charlottesville, Virginia, United States, 22904
Sponsors and Collaborators
University of Virginia
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Arthur Weltman, PhD University of Virginia
Study Director: Brian A Irving, PhD University of Virginia
  More Information

Responsible Party: Arthur Weltman/Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT00350064     History of Changes
Other Study ID Numbers: UVAHIC11145
First Submitted: July 6, 2006
First Posted: July 10, 2006
Last Update Posted: August 8, 2008
Last Verified: August 2008

Keywords provided by University of Virginia:
Metabolic Syndrome
Obesity
Exercise
Diabetes
Physical Activity

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases