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

Not Applicable

• Conditions: Metabolic Syndrome

• Registration Number: NCT00350064
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-06
• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-10
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-07
• Last Update Posted: 2008-08-08
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in Abdominal Visceral Fat	before and after 16 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Virginia General Clinical Research Center; 🇺🇸 Charlottesville, Virginia, United States