Status:
UNKNOWN
The Effects of Exenatide After Gastric Restriction
Lead Sponsor:
Advanced Specialty Care
Conditions:
Morbid Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 inject...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00872378
Start Date
February 1 2009
End Date
December 1 2010
Last Update
March 31 2009
Active Locations (2)
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1
Advanced Specialty Care
Bend, Oregon, United States, 97701
2
Endocrinology Services NorthWest
Bend, Oregon, United States, 97701