AGREE: The Effects of Exenatide After Gastric Restriction

Sponsor

Advanced Specialty Care (Other)

Overall Status

Unknown status

CT.gov ID

NCT00872378

Collaborator

(none)

Enrollment

Locations

Arms

21.9

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Drug: Exenatide Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Exenatide Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program	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). Other Names: BYETTA
Placebo Comparator: Placebo Laparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program	Drug: 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).

Arm

Intervention/Treatment

Active Comparator: Exenatide

Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program

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).

Other Names:

BYETTA

Placebo Comparator: Placebo

Laparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program

Drug: 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).

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Body Mass Index (BMI) [52 Weeks]
Waist circumference [52 Weeks]
Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c [52 Weeks]
Carotid intima media thickness(CIMT) [52 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.