The Effects of Exenatide After Gastric Restriction
Information source: Advanced Specialty Care
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Morbid Obesity
Intervention: Exenatide (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Advanced Specialty Care Official(s) and/or principal investigator(s):
Patrick J McCarthy, M.D., Principal Investigator, Affiliation: Endocrinology Services NorthWest
Overall contact:
Megan E Boone, BS, Phone: 541-322-1772, Email: megan@advancedspecialtycare.com
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Body Mass Index (BMI)Waist circumference Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c Carotid intima media thickness(CIMT)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Megan E Boone, BS, Phone: 541-322-1772, Email: megan@advancedspecialtycare.com
Advanced Specialty Care, Bend, Oregon 97701, United States; Recruiting
Megan E Boone, BS, Phone: 541-322-1772, Email: megan@advancedspecialtycare.com
Ngocthuy Hughes, MD, Sub-Investigator
Stephen B Archer, MD FACS, Sub-Investigator
Endocrinology Services NorthWest, Bend, Oregon 97701, United States; Recruiting
Megan E Boone, BS, Phone: 541-322-1772, Email: megan@advancedspecialtycare.com
Patrick J McCarthy, MD, Principal Investigator
Travis L Monchamp, MD, Sub-Investigator
Additional Information
Starting date: February 2009
Last updated: March 30, 2009
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