Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Virginia.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Virginia
Collaborator:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00350064
First received: July 6, 2006
Last updated: August 7, 2008
Last verified: August 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metabolic Syndrome |
Behavioral: Exercise Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome |
Resource links provided by NLM:
Further study details as provided by University of Virginia:
Primary Outcome Measures:
- Change in Abdominal Visceral Fat [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- VO2peak [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- % Body Fat [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- Insulin [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- FFA [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- Glucose [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- Hba1c [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- Cholesterol [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- CRP [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- IL6 [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- TNF [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- Homocysteine [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- Adiponectin [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- Adhesion Molecules [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
- Endothelial Function [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 165 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Behavioral: Exercise Training
16 weeks of aerobic exercise training at two different intensities
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350064
Locations
| United States, Virginia | |
| University of Virginia General Clinical Research Center | |
| Charlottesville, Virginia, United States, 22904 | |
Sponsors and Collaborators
University of Virginia
Investigators
| Principal Investigator: | Arthur Weltman, PhD | University of Virginia |
| Study Director: | Brian A Irving, PhD | University of Virginia |
More Information
No publications provided
| Responsible Party: | Arthur Weltman/Principal Investigator, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00350064 History of Changes |
| Other Study ID Numbers: | UVAHIC11145 |
| Study First Received: | July 6, 2006 |
| Last Updated: | August 7, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
Metabolic Syndrome Obesity Exercise Diabetes Physical Activity |
Additional relevant MeSH terms:
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013