Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

Study Overview
=================
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.

Official Title
-----------------
Exercise in Patients With Metabolic Syndrome and Weight Regain - Echocardiography Substudy

Conditions
-----------------
Metabolic Syndrome, Obesity

Intervention / Treatment
-----------------
* Procedure: Stress Echocardiography


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Echocardiography<br>Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol. | Procedure: Stress Echocardiography<br>* Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, obesity, exercise