The Effects of Exenatide After Gastric Restriction

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of the Effects of BYETTA® (Exenatide) on Weight Loss in Morbidly Obese Non Diabetic Patients Following Adjustable Gastric Banding

Conditions
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Morbid Obesity

Intervention / Treatment
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* Drug: Exenatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years, Have a body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities (1991 NIH Guidelines for Bariatric Surgery), For women of childbearing age, must have a negative pregnancy test at screening, and agree to use barrier contraceptives for the duration of the study, AND Are able to understand and comply with the study process, and give informed consent. Exclusion Criteria: A diagnosis of type 1 diabetes mellitus, A diagnosis of type 2 diabetes mellitus (A diagnosis of T2DM will be a previous fasting plasma glucose greater than or equal to 126 mg/dL, or a random plasma glucose greater than 200 mg/dL), Have experienced hypersensitivity reaction or a worsening of glycemic control on Byetta® (exenatide), Patients with end stage renal disease or severe renal impairment, Patients with severe gastrointestinal disease, including gastroparesis, Liver function tests 2.5 standard deviations above normal values, Contraindication for bariatric surgery, Treatment with exenatide (Byetta) in the last three months, Currently using or have used within three months before this trial: sibutramine, orlistat, or phentermine(patients must also agree to not use these medications for the duration of the study), Treatment with any investigational drug in the last 30 days, Active malignancy, liver of kidney failure, symptomatic coronary heart disease, or severe psychiatric disease, History of malignancy other than basal cell skin carcinoma, OR In the opinion of the investigator, patient is abusing alcohol and/or drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exenatide<br>Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program | Drug: Exenatide<br>* 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).<br>* Other names: BYETTA;|
| Placebo Comparator: Placebo<br>Laparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program | Drug: Placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 52 Weeks | 
| Carotid intima media thickness(CIMT) |  | 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, LAP Band, Adjustable Gastric Band, Exenatide, Byetta, Weight Loss, Bariatric Surgery