Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2 (LBMI)

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Heekoung A Youn, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00580502
First received: December 21, 2007
Last updated: March 16, 2015
Last verified: March 2015
  Purpose

This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.


Condition Intervention Phase
Obesity
Device: LAP-BAND® Adjustable Gastric Band (LAGB®)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Safety and Efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) Operations for Patients With BMI Between 30-40 kg/m2 With Co-morbidities

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.


Secondary Outcome Measures:
  • Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in level of LDL from baseline at 5 years

  • Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in level of Triglycerides from baseline at 5 years

  • Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in level of HbA1c from baseline at 5 years


Enrollment: 50
Study Start Date: March 2004
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAGB for low BMI patients
the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
Device: LAP-BAND® Adjustable Gastric Band (LAGB®)
Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2

Detailed Description:

TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities

CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA

STUDY OBJECTIVES

  • To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
  • To determine long-term effects on patients' co-morbidities

STUDY VARIABLES: Morbidity & mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation

DESIGN: Prospective single center study

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 18 and equal to or less than 60 years of age.
  • BMI of at least 30 and maximum BMI of 40 with co-morbidities
  • Willingness to comply with dietary restrictions required by the protocol
  • History of obesity for at least 5 years
  • History of at least 6 months of documented failures with traditional non-surgical weight loss methods
  • Willingness to follow protocol requirements
  • If female with childbearing potential, using an appropriate form of contraception

Exclusion Criteria:

  • Age less than 18, age greater than 60
  • Pregnancy
  • History of major depressive disorder or psychosis
  • Previous bariatric surgery or previous gastric surgery
  • Presence of achalasia
  • Presence of portal hypertension, cirrhosis, and/or varices
  • Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease
  • Patients with autoimmune connective tissue disorders
  • Patients with acute abdominal infections
  • Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580502

Sponsors and Collaborators
New York University School of Medicine
Allergan
Investigators
Principal Investigator: Christine Ren-Fielding, M.D. NYUSOM
  More Information

Additional Information:
No publications provided

Responsible Party: Heekoung A Youn, Research coordinator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00580502     History of Changes
Other Study ID Numbers: H # 10686, 10686, G030190
Study First Received: December 21, 2007
Results First Received: December 29, 2014
Last Updated: March 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Obesity, 50 lbs overweight

ClinicalTrials.gov processed this record on August 27, 2015