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
Sponsor:
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

July 6, 2006
August 7, 2008
April 2004
June 2006   (final data collection date for primary outcome measure)
Change in Abdominal Visceral Fat [ Time Frame: before and after 16 weeks ] [ Designated as safety issue: No ]
Change in Abdominal Visceral Fat
Complete list of historical versions of study NCT00350064 on ClinicalTrials.gov Archive Site
  • 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 ]
  • VO2peak
  • % Body Fat
  • Insulin
  • FFA
  • Glucose
  • Hba1c
  • Cholesterol
  • CRP
  • IL6
  • TNF
  • Homocysteine
  • Adiponectin
  • Adhesion Molecules
  • Endothelial Function
Not Provided
Not Provided
 
Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Metabolic Syndrome
Behavioral: Exercise Training
16 weeks of aerobic exercise training at two different intensities
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
165
December 2008
June 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00350064
UVAHIC11145
No
Arthur Weltman/Principal Investigator, University of Virginia
University of Virginia
National Center for Research Resources (NCRR)
Principal Investigator: Arthur Weltman, PhD University of Virginia
Study Director: Brian A Irving, PhD University of Virginia
University of Virginia
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP