Status:
UNKNOWN
Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-85 years
Phase:
NA
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 low...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00350064
Start Date
April 1 2004
End Date
December 1 2008
Last Update
August 8 2008
Active Locations (1)
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1
University of Virginia General Clinical Research Center
Charlottesville, Virginia, United States, 22904