Clinical trial NCT00872378: The Effects of Exenatide After Gastric Restriction
Official title: A Pilot Study of the Effects of BYETTA® (Exenatide) on Weight Loss in Morbidly Obese Non Diabetic Patients Following Adjustable Gastric Banding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Morbid Obesity
Keywords: Morbid Obesity
LAP Band
Adjustable Gastric Band
Exenatide
Byetta
Weight Loss
Bariatric Surgery
Lead sponsor: Advanced Specialty Care
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 52 weeks
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 52 Weeks
measure: Waist circumference
timeFrame: 52 Weeks
measure: Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c
timeFrame: 52 Weeks
measure: Carotid intima media thickness(CIMT)
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Bend
country: United States
facility: Advanced Specialty Care
state: Oregon
city: Bend
country: United States
facility: Endocrinology Services NorthWest
state: Oregon
Study officials:
affiliation: Endocrinology Services NorthWest
name: Patrick J McCarthy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: