The Effects of Exenatide After Gastric Restriction

Morbid Obesity Clinical Trial

— AGREE  

Official title:

A Pilot Study of the Effects of BYETTA® (Exenatide) on Weight Loss in Morbidly Obese Non Diabetic Patients Following Adjustable Gastric Banding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00872378
• Other study ID #: ASC-AGREE Study
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 27, 2009
• Last updated: March 30, 2009
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2009
• Source: Advanced Specialty Care
• Contact: Megan E Boone, BS
• Phone: 541-322-1772
• Email: megan[@]advancedspecialtycare.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
United States	Advanced Specialty Care	Bend	Oregon
United States	Endocrinology Services NorthWest	Bend	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Specialty Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Body Mass Index (BMI)		52 Weeks	No
Secondary	Waist circumference		52 Weeks	No
Secondary	Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c		52 Weeks	No
Secondary	Carotid intima media thickness(CIMT)		52 Weeks	No