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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC1DK086132 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This research study will investigate the safety and effectiveness of weight loss surgery for overweight persons with type 2 diabetes. Eligible patients will undergo one of 2 types of weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding, or an intensive lifestyle modification. Participants will be closely followed for one year to compare the effects of these treatments on diabetes remission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roux-en-Y Gastric Bypass surgery | Active Comparator | Surgical intervention for weight loss |
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| Laparoscopic Adjustable Gastric Banding surgery | Active Comparator | Surgical intervention for weight loss |
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| Intensive Lifestyle Modification | Active Comparator | Lifestyle intervention for weight loss |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roux-en-Y Gastric Bypass surgery | Procedure | Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to compare the rates of diabetes remission over one year. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives of this study are to determine the effects of the three treatment conditions on insulin sensitivity, endogenous glucose production, postprandial insulin release, and levels of gut hormones (including GLP-1). | One year | |
| To compare other benefits (e.g., improvements in quality of life, dietary intake, and physical activity), as well as risks (e.g., hypoglycemia, cholecystitis, early and late surgical complications), of the three interventions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David B Sarwer, Ph.D. | University of Pennsylvania | Principal Investigator |
| Thomas A Wadden, Ph.D. | University of Pennsylvania | Principal Investigator |
| Noel Williams, M.D. | University of Pennsylvania Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Center for Weight and Eating Disorders | Philadelphia | Pennsylvania | 19104 | United States |
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| Label | URL |
|---|---|
| Center for Weight and Eating Disorders website | View source |
| Bariatric Surgery Program at Penn website | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Laparoscopic Adjustable Gastric Banding surgery | Procedure | Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits. |
|
| Intensive Lifestyle Modification | Behavioral | Intensive lifestyle modification program for weight loss. Participants randomized to this condition will receive an weekly individual treatment of 30 minutes for the first 6 months and every-other-week sessions from months 7 to 12. Treatment will be provided by a behavioral psychologist or registered dietitian following a structured curriculum used in our prior studies. During the first 4 months, participants will be prescribed a 1000-1200 kcal/d diet that provides four daily servings of meal replacement products (liquid shakes, cereals, meal bars, etc), combined with an evening dinner entree. Each serving of the meal replacement (HMR 170; Boston, MA) will provide 170 calories, with 16 g of protein, 22 g of carbohydrate, and 2 g of fat. Dinner entrees (containing at least 20 g of protein and approximately 220-260 kcal) will be consumed with a garden salad and a serving of fruit (and other vegetables allowed ad libitum throughout the day). |
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| One year |
| To examine the attitudes that patients, health care professionals, and insurance providers have toward the use of bariatric surgery to treat type 2 diabetes. | One year |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D006946 | Hyperinsulinism |