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

Status unconfirmed · Not applicable

Conditions studied: Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT00350064

Run by

University of Virginia

People needed

165

Starts

2004-04-01

Expected to finish

2008-12-01

Last updated by the study team

2008-08-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Virginia General Clinical Research Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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