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| ID | Type | Description | Link |
|---|---|---|---|
| MS vs. MM for DM2 | Other Identifier | Dept identifier |
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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).
Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best Medical Management | Active Comparator | Patients elect to treat obesity and type 2 diabetes mellitus through best medical management. |
|
| Surgical Treatment | Active Comparator | Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory evaluations, sleep study | Other | Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test. | 2 years | |
| Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in glucose control | 2 years | |
| Improvement in control of chronic co-morbidities | 2 years | |
| Identify predictors of success with regard to improved co-morbidities and velocity of weight loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asem Ali, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Best Medical Management | Other | Standard of care. |
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| Roux-en-Y gastric bypass surgery | Procedure | Surgical treatment. |
|
| 2 years |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |