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| Name | Class |
|---|---|
| American Society for Metabolic and Bariatric Surgery | OTHER |
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Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.
Same as above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| baratric surgery | Other | surgery vs.weight loss program 6 months prior to bariatric surgery |
|
| pre-bariatric weight loss program | Other | weight loss program prior to bariatric surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-bariatric weight loss program | Behavioral | standard 6 month physician directed pre-bariatric weight loss program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Late Outgrowth Endothelial Progenitor Colonies | Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT). | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William O Richards, MD | University of South Alabama, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36617 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baratric Surgery | surgery vs.weight loss program 6 months prior to bariatric surgery bariatric surgery: bariatric surgery for weight loss |
| FG001 | Pre-bariatric Weight Loss Program | weight loss program prior to bariatric surgery pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baratric Surgery | surgery vs.weight loss program 6 months prior to bariatric surgery bariatric surgery: bariatric surgery for weight loss |
| BG001 | Pre-bariatric Weight Loss Program |
| 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 | Change in Late Outgrowth Endothelial Progenitor Colonies | Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT). | Study population of patients undergoing bariatric surgery compared to a group of morbidly obese patients undergoing medical diet therapy pre bariatric surgery | Posted | Mean | Standard Error | LOEPC colonies | 24 months |
|
baseline to 6 months
Serious adverse events were identified through regular investigator assessment.
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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 | Baratric Surgery | surgery vs.weight loss program 6 months prior to bariatric surgery bariatric surgery: bariatric surgery for weight loss |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William O. Richards, MD | University of South Alabama, Department of Surgery | 251-471-7993 | brichards@health.southalabama.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061217 | Weight Reduction Programs |
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D006293 | Health Promotion |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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| bariatric surgery | Procedure | bariatric surgery for weight loss |
|
weight loss program prior to bariatric surgery
pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| body mass index | Mean | Full Range | kg/m2 |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Pre-bariatric Weight Loss Program | weight loss program prior to bariatric surgery pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program | 0 | 6 | 0 | 6 | 0 | 6 |
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| D004700 | Endocrine System Diseases |
| D005159 |
| Health Care Facilities Workforce and Services |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |