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Completed

NCT Number: NCT00543985

Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

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.

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Key information

Conditions

Metabolic Syndrome Behavior Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Echocardiography

Procedure

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

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2007
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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