Morbid Obesity
Conditions
Keywords
Morbid Obesity, LAP Band, Adjustable Gastric Band, Exenatide, Byetta, Weight Loss, Bariatric Surgery
Brief summary
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.
Interventions
DRUGExenatide
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).
DRUGPlacebo
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).
Sponsors
Advanced Specialty Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years, 2. Have a body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities (1991 NIH Guidelines for Bariatric Surgery), 3. 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 4. Are able to understand and comply with the study process, and give informed consent.
Exclusion criteria
1. A diagnosis of type 1 diabetes mellitus, 2. 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), 3. Have experienced hypersensitivity reaction or a worsening of glycemic control on Byetta® (exenatide), 4. Patients with end stage renal disease or severe renal impairment, 5. Patients with severe gastrointestinal disease, including gastroparesis, 6. Liver function tests 2.5 standard deviations above normal values, 7. Contraindication for bariatric surgery, 8. Treatment with exenatide (Byetta) in the last three months, 9. 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), 10. Treatment with any investigational drug in the last 30 days, 11. Active malignancy, liver of kidney failure, symptomatic coronary heart disease, or severe psychiatric disease, 12. History of malignancy other than basal cell skin carcinoma, OR 13. In the opinion of the investigator, patient is abusing alcohol and/or drugs.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Contacts
Primary ContactMegan E Boone, BS
Outcome results
None listed