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

August 7, 2008 updated by: University of Virginia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • University of Virginia General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Abdominal Visceral Fat
Time Frame: before and after 16 weeks
before and after 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arthur Weltman, PhD, University of Virginia
  • Study Director: Brian A Irving, PhD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Anticipated)

June 1, 2006

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Estimate)

August 8, 2008

Last Update Submitted That Met QC Criteria

August 7, 2008

Last Verified

August 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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