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The Effects of Exenatide After Gastric Restriction (AGREE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Advanced Specialty Care.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872378
First Posted: March 31, 2009
Last Update Posted: March 31, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Advanced Specialty Care
  Purpose
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 Intervention Phase
Morbid Obesity Drug: Exenatide Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Advanced Specialty Care:

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. [ Time Frame: 52 weeks ]

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

Estimated Enrollment: 28
Study Start Date: February 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872378


Contacts
Contact: Megan E Boone, BS 541-322-1772 megan@advancedspecialtycare.com

Locations
United States, Oregon
Advanced Specialty Care Recruiting
Bend, Oregon, United States, 97701
Contact: Megan E Boone, BS    541-322-1772    megan@advancedspecialtycare.com   
Sub-Investigator: Ngocthuy Hughes, MD         
Sub-Investigator: Stephen B Archer, MD FACS         
Endocrinology Services NorthWest Recruiting
Bend, Oregon, United States, 97701
Contact: Megan E Boone, BS    541-322-1772    megan@advancedspecialtycare.com   
Principal Investigator: Patrick J McCarthy, MD         
Sub-Investigator: Travis L Monchamp, MD         
Sponsors and Collaborators
Advanced Specialty Care
Investigators
Principal Investigator: Patrick J McCarthy, M.D. Endocrinology Services NorthWest
  More Information

Responsible Party: Patrick J. McCarthy M.D., Endocrinologist, Endocrinology Services NorthWest
ClinicalTrials.gov Identifier: NCT00872378     History of Changes
Other Study ID Numbers: ASC-AGREE Study
First Submitted: March 27, 2009
First Posted: March 31, 2009
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by Advanced Specialty Care:
Morbid Obesity
LAP Band
Adjustable Gastric Band
Exenatide
Byetta
Weight Loss
Bariatric Surgery

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists