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Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00543985
First received: October 11, 2007
Last updated: November 21, 2016
Last verified: November 2016
  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: 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: Immediately prior to exercise ]
    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: Immediately following treadmill stress test ]
    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:
  • Change in Maximal Oxygen Uptake (VO2 Max) [ Time Frame: Immediately prior to exercise ]
    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: Immediately following treadmill stress test ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 11, 2007
Results First Received: January 11, 2010
Last Updated: November 21, 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

ClinicalTrials.gov processed this record on February 24, 2017