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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK067036 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Echocardiography | Experimental | Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Echocardiography | Procedure | Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom R Thomas, PhD | University of Missouri-Columbia | Principal Investigator |
| Kevin C Dellsperger, MD, PhD | University of Missouri-Columbia | Study Director |
| Anand Chockalingam, MD | University of Missouri-Columbia | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19523060 | Result | 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. |
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All patients in this study had successfully been screened as part of the parent study. All patients were to exercise (aerobic) and have a 10% weight loss. Echocardiography was performed prior to and immediately following a maximal stress test at the end of 12 weeks of exercise.
Patients were recruited as part of the parent study on Weight Regain (PI Tom Thomas) funded by NIH. These patients were recruited from clinics, volunteers from advertisements. Patients needed to have 2 of 5 criteria for the Metabolic Syndrome (MetS) plus have obesity.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stress Echocardiography | Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stress Echocardiography | Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' and VO2 max. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The echo results from all subjects were analyzed at rest and following maximal exercise testing. | Posted | Mean | Standard Error | ml/min/kg | 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stress Echocardiography | Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' . |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin C. Dellsperger, MD, PhD, Professor, Internal Medicine | University of Missouri | 573-884-2013 | dellspergerk@health.missouri.edu |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | The echo results from all subjects were analyzed at rest and following maximal exercise testing. | Posted | Mean | Standard Error | ml/min/kg | 12 weeks |
|
|
|
| Secondary | 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. | This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available. | Posted | 12 weeks |
|
|
| Secondary | 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. | This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available. | Posted | 12 weeks |
|
|
| 0 |
| 32 |
| 0 |
| 32 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |