Recruiting
Phase 2
Phase 3

Exenatide

Sponsor:

Advanced Specialty Care

Code:

NCT00872378

Conditions

Morbid Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exenatide

Placebo

Study Details

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.

Conditions

Morbid Obesity

Study ID

NCT00872378

Start date

Feb, 2009

Status verified date

Mar, 2009

Completion date

Dec, 2010

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Exenatide

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

placebo comparator: Placebo

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

Interventions

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).

Primary outcome 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. [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Locations

Advanced Specialty Care

Recruiting

Bend, Oregon, United States, 97701

Contacts

Endocrinology Services NorthWest

Recruiting

Bend, Oregon, United States, 97701

Contacts

Principal Investigator:

Patrick J McCarthy, MD

More Information

Sponsor

Advanced Specialty Care

Last update posted

Mar 31, 2009

Last verified

Mar, 2009

Keywords

  • Morbid Obesity
  • LAP Band
  • Adjustable Gastric Band
  • Exenatide
  • Byetta
  • Weight Loss
  • Bariatric Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Advanced Specialty Care on 2009-03-31.