Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
28 participants
INTERVENTIONAL
2009-02-28
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Exenatide
Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program
Exenatide
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).
Placebo
Laparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program
Placebo
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).
Interventions
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Exenatide
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).
Placebo
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Advanced Specialty Care
OTHER
Responsible Party
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Endocrinology Services NorthWest
Principal Investigators
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Patrick J McCarthy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Endocrinology Services NorthWest
Locations
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Advanced Specialty Care
Bend, Oregon, United States
Endocrinology Services NorthWest
Bend, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Megan E Boone, BS
Role: primary
Megan E Boone, BS
Role: primary
Other Identifiers
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ASC-AGREE Study
Identifier Type: -
Identifier Source: org_study_id