The Effects of Exenatide After Gastric Restriction (AGREE)

March 30, 2009 updated by: Advanced Specialty Care

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Advanced Specialty Care
        • Contact:
        • Sub-Investigator:
          • Ngocthuy Hughes, MD
        • Sub-Investigator:
          • Stephen B Archer, MD FACS
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Endocrinology Services NorthWest
        • Contact:
        • Principal Investigator:
          • Patrick J McCarthy, MD
        • Sub-Investigator:
          • Travis L Monchamp, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exenatide
Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patrick J McCarthy, M.D., Endocrinology Services NorthWest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (Estimate)

March 31, 2009

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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