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

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
University of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Obesity, Exercise, Diabetes, Physical Activity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: 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 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.

Sites / Locations

  • University of Virginia General Clinical Research Center

Outcomes

Primary Outcome Measures

Change in Abdominal Visceral Fat

Secondary Outcome Measures

VO2peak
% Body Fat
Insulin
FFA
Glucose
Hba1c
Cholesterol
CRP
IL6
TNF
Homocysteine
Adiponectin
Adhesion Molecules
Endothelial Function

Full Information

First Posted
July 6, 2006
Last Updated
August 7, 2008
Sponsor
University of Virginia
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00350064
Brief Title
Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
Official Title
Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
June 2006 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, Obesity, Exercise, Diabetes, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Exercise Training
Intervention Description
16 weeks of aerobic exercise training at two different intensities
Primary Outcome Measure Information:
Title
Change in Abdominal Visceral Fat
Time Frame
before and after 16 weeks
Secondary Outcome Measure Information:
Title
VO2peak
Time Frame
before and after 16 weeks
Title
% Body Fat
Time Frame
before and after 16 weeks
Title
Insulin
Time Frame
before and after 16 weeks
Title
FFA
Time Frame
before and after 16 weeks
Title
Glucose
Time Frame
before and after 16 weeks
Title
Hba1c
Time Frame
before and after 16 weeks
Title
Cholesterol
Time Frame
before and after 16 weeks
Title
CRP
Time Frame
before and after 16 weeks
Title
IL6
Time Frame
before and after 16 weeks
Title
TNF
Time Frame
before and after 16 weeks
Title
Homocysteine
Time Frame
before and after 16 weeks
Title
Adiponectin
Time Frame
before and after 16 weeks
Title
Adhesion Molecules
Time Frame
before and after 16 weeks
Title
Endothelial Function
Time Frame
before and after 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Weltman, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian A Irving, PhD
Organizational Affiliation
University of Virginia
Official's Role
Study Director
Facility Information:
Facility Name
University of Virginia General Clinical Research Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States

12. IPD Sharing Statement

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

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