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

NCT ID: NCT00350064

Last Updated: 2008-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Keywords

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Metabolic Syndrome Obesity Exercise Diabetes Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Exercise Training

16 weeks of aerobic exercise training at two different intensities

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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University of Virginia

Principal Investigators

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Arthur Weltman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Brian A Irving, PhD

Role: STUDY_DIRECTOR

University of Virginia

Locations

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University of Virginia General Clinical Research Center

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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UVAHIC11145

Identifier Type: -

Identifier Source: org_study_id