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Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

Primary Purpose

Metabolic Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stress Echocardiography
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metabolic Syndrome focused on measuring metabolic syndrome, obesity, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Stress Echocardiography

    Arm Description

    Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.

    Outcomes

    Primary Outcome Measures

    Mean Resting E/E'
    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'
    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)
    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)
    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.

    Full Information

    First Posted
    October 11, 2007
    Last Updated
    January 17, 2017
    Sponsor
    University of Missouri-Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00543985
    Brief Title
    Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)
    Official Title
    Exercise in Patients With Metabolic Syndrome and Weight Regain - Echocardiography Substudy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Missouri-Columbia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Obesity
    Keywords
    metabolic syndrome, obesity, exercise

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stress Echocardiography
    Arm Type
    Experimental
    Arm Description
    Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
    Intervention Type
    Procedure
    Intervention Name(s)
    Stress Echocardiography
    Intervention Description
    Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
    Primary Outcome Measure Information:
    Title
    Mean Resting E/E'
    Description
    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.
    Time Frame
    12 weeks
    Title
    Post-exercise E/E'
    Description
    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.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Mean Resting Maximal Oxygen Uptake (VO2 Max)
    Description
    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.
    Time Frame
    12 weeks
    Title
    Change in Maximal Oxygen Uptake (VO2 Max)
    Description
    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.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tom R Thomas, PhD
    Organizational Affiliation
    University of Missouri-Columbia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kevin C Dellsperger, MD, PhD
    Organizational Affiliation
    University of Missouri-Columbia
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Anand Chockalingam, MD
    Organizational Affiliation
    University of Missouri-Columbia
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19523060
    Citation
    Chockalingam A, Linden MA, Dellsperger KC, Thomas TR. Correlation of Normal Diastolic Cardiac Function With VO in the Metabolic Syndrome. Prev Cardiol. 2009 Summer;12(3):163-8. doi: 10.1111/j.1751-7141.2009.00027.x.
    Results Reference
    result

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    Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

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