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The purpose of this study is to describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or placebo injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Active Comparator | Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program |
|
| Placebo | Placebo Comparator | Laparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | Exenatide titrated up to 20mcg BID. (4 weeks at 5mcg BID; 4 weeks at 10mcg BID; 4 weeks at 15mcg BID; 37 weeks at 20mcg BID). |
|
| Measure | Description | Time Frame |
|---|---|---|
| To describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | 52 Weeks | |
| Waist circumference | 52 Weeks | |
| Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan E Boone, BS | Contact | 541-322-1772 | megan@advancedspecialtycare.com |
| Name | Affiliation | Role |
|---|---|---|
| Patrick J McCarthy, M.D. | Endocrinology Services NorthWest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Specialty Care | Recruiting | Bend | Oregon | 97701 | United States |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Placebo | Drug | Placebo titrated up to 20mcg BID. (4 weeks at 5mcg BID; 4 weeks at 10mcg BID; 4 weeks at 15mcg BID; 37 weeks at 20mcg BID). |
|
| 52 Weeks |
| Carotid intima media thickness(CIMT) | 52 Weeks |
| Endocrinology Services NorthWest | Recruiting | Bend | Oregon | 97701 | United States |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |