Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Obesity
• Interventions: Procedure: Stress Echocardiography

• Registration Number: NCT00543985
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2010-01-11
• Results First Submitted QC: 2016-09-29
• Status Verified: 2016-11
• Results First Posted: 2016-11-22
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Resting E/E'	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'	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

Name	Time	Method
Change in Maximal Oxygen Uptake (VO2 Max)	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.
Mean Resting Maximal Oxygen Uptake (VO2 Max)	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.