NCT00872378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

1.8 years

First QC Date

March 27, 2009

Last Update Submit

March 30, 2009

Conditions

Morbid Obesity

Keywords

Morbid ObesityLAP BandAdjustable Gastric BandExenatideByettaWeight LossBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Exenatide

ACTIVE COMPARATOR

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

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ExenatideDRUG

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).

Also known as: BYETTA
Exenatide
PlaceboDRUG

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).

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Advanced Specialty Care

Bend, Oregon, 97701, United States

RECRUITING

Endocrinology Services NorthWest

Bend, Oregon, 97701, United States

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Interventions

Exenatide

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Patrick J McCarthy, M.D.

    Endocrinology Services NorthWest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan E Boone, BS

CONTACT

541-322-1772megan@advancedspecialtycare.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 31, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

US(2)