Metabolic Syndrome, Obesity
Conditions
Keywords
metabolic syndrome, obesity, exercise
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.
Interventions
PROCEDUREStress Echocardiography
Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
Sponsors
University of Missouri-Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Stress Echocardiography |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 2 |
| Gender Female | 15 Participants |
| Gender Male | 17 Participants |
| Region of Enrollment United States | 32 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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.
Time frame: 12 weeks
Population: The echo results from all subjects were analyzed at rest and following maximal exercise testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stress Echocardiography | Mean Resting E/E' | 7.01 ml/min/kg | Standard Error 0.37 |
Comparison: Pearson Product correlation was used to determine relationships between resting E/E' and Exercise VO2 max and Stress E/E' and Exercise VO2max.p-value: =0.14Regression, Linear
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.
Time frame: 12 weeks
Population: The echo results from all subjects were analyzed at rest and following maximal exercise testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stress Echocardiography | Post-exercise E/E' | 7.41 ml/min/kg | Standard Error 0.41 |
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.
Time frame: 12 weeks
Population: This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.
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.
Time frame: 12 weeks
Population: This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.