- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350064
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
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:
- 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.
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.
Sponsor
Collaborators
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UVAHIC11145
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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