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Clinical Trials/NCT00350064
NCT00350064
Unknown
Not Applicable

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

University of Virginia1 site in 1 country165 target enrollmentApril 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
University of Virginia
Enrollment
165
Locations
1
Primary Endpoint
Change in Abdominal Visceral Fat
Last Updated
17 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
December 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Eligibility 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:
  • visit the outpatient GCRC or clinic once monthly for 16 weeks of intervention,
  • participate in supervised exercise training (if assigned) and
  • 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),

Outcomes

Primary Outcomes

Change in Abdominal Visceral Fat

Time Frame: before and after 16 weeks

Secondary Outcomes

  • Adhesion Molecules(before and after 16 weeks)
  • VO2peak(before and after 16 weeks)
  • % Body Fat(before and after 16 weeks)
  • Insulin(before and after 16 weeks)
  • FFA(before and after 16 weeks)
  • Glucose(before and after 16 weeks)
  • Hba1c(before and after 16 weeks)
  • Cholesterol(before and after 16 weeks)
  • CRP(before and after 16 weeks)
  • IL6(before and after 16 weeks)
  • TNF(before and after 16 weeks)
  • Homocysteine(before and after 16 weeks)
  • Adiponectin(before and after 16 weeks)
  • Endothelial Function(before and after 16 weeks)

Study Sites (1)

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