Back to results

The Effects of Exenatide After Gastric Restriction (AGREE)

Primary Purpose

Morbid Obesity

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Exenatide

Placebo

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid Obesity, LAP Band, Adjustable Gastric Band, Exenatide, Byetta, Weight Loss, Bariatric Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Advanced Specialty CareRecruiting
Endocrinology Services NorthWestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exenatide

Placebo

Arm Description

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

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

Outcomes

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.

Secondary Outcome Measures

Body Mass Index (BMI)

Waist circumference

Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c

Carotid intima media thickness(CIMT)

Full Information

NCT ID

NCT00872378

First Posted

March 27, 2009

Last Updated

March 30, 2009

Sponsor

Advanced Specialty Care

1. Study Identification

Unique Protocol Identification Number

NCT00872378

Brief Title

The Effects of Exenatide After Gastric Restriction

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Advanced Specialty Care

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exenatide

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Exenatide

Other Intervention Name(s)

BYETTA

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Information:

Title

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Body Mass Index (BMI)

Time Frame

52 Weeks

Title

Waist circumference

Time Frame

52 Weeks

Title

Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c

Time Frame

52 Weeks

Title

Carotid intima media thickness(CIMT)

Time Frame

52 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Megan E Boone, BS

Phone

541-322-1772

megan@advancedspecialtycare.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick J McCarthy, M.D.

Organizational Affiliation

Endocrinology Services NorthWest

Official's Role

Principal Investigator

Facility Information:

Facility Name

Advanced Specialty Care

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Megan E Boone, BS

Phone

541-322-1772

megan@advancedspecialtycare.com

First Name & Middle Initial & Last Name & Degree

Ngocthuy Hughes, MD

First Name & Middle Initial & Last Name & Degree

Stephen B Archer, MD FACS

Facility Name

Endocrinology Services NorthWest

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Megan E Boone, BS

Phone

541-322-1772

megan@advancedspecialtycare.com

First Name & Middle Initial & Last Name & Degree

Patrick J McCarthy, MD

First Name & Middle Initial & Last Name & Degree

Travis L Monchamp, MD

12. IPD Sharing Statement

Learn more about this trial

The Effects of Exenatide After Gastric Restriction

We'll reach out to this number within 24 hrs