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Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543985
First Posted: October 15, 2007
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Missouri-Columbia
  Purpose
We plan to test the hypothesis that patients with metabolic syndrome will have impaired left ventricular diastolic parameters. These parameters will be measured before and after a stress test at the end of a 3 month period of exercise training and a 10% weight loss.

Condition Intervention
Metabolic Syndrome Obesity Procedure: Stress Echocardiography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exercise in Patients With Metabolic Syndrome and Weight Regain - Echocardiography Substudy

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Mean Resting E/E' [ Time Frame: 12 weeks ]
    E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants prior to treadmill stress test.

  • Post-exercise E/E' [ Time Frame: 12 weeks ]
    E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants immediately following treadmill stress test.


Secondary Outcome Measures:
  • Mean Resting Maximal Oxygen Uptake (VO2 Max) [ Time Frame: 12 weeks ]
    Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min). Measured in all participants prior to treadmill stress test.

  • Change in Maximal Oxygen Uptake (VO2 Max) [ Time Frame: 12 weeks ]
    Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min) Measured in all participants immediately following treadmill stress test.


Enrollment: 36
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stress Echocardiography
Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
Procedure: Stress Echocardiography
Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.

Detailed Description:
Patients must have 2 of the 5 criteria for metabolic syndrome and be able to exercise in a monitored setting for 45 min 5 times a week.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2 of 5 criteria for metabolic syndrome
  • Ability to exercise for 45 min 5 days a week

Exclusion Criteria:

  • No diabetes
  • Established coronary disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543985


Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Tom R Thomas, PhD University of Missouri-Columbia
Study Director: Kevin C Dellsperger, MD, PhD University of Missouri-Columbia
Study Director: Anand Chockalingam, MD University of Missouri-Columbia
  More Information

Publications:
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00543985     History of Changes
Other Study ID Numbers: R01DK067036 (Echo substudy)
R01DK067036 ( U.S. NIH Grant/Contract )
First Submitted: October 11, 2007
First Posted: October 15, 2007
Results First Submitted: January 11, 2010
Results First Posted: November 22, 2016
Last Update Posted: March 1, 2017
Last Verified: November 2016

Keywords provided by University of Missouri-Columbia:
metabolic syndrome
obesity
exercise

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases