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

NCT00580502 | Completed Phase 2 Results DMC

• 3 other identifiers: H # 1068610686G030190
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity, 50 lbs overweight

Outcome Measures

Primary Outcomes (1)

• To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery

  Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.

  5 years

Secondary Outcomes (3)

• Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery

  5 years

• Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery

  5 years

• Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery

  5 years

Study Arms (1)

LAGB for low BMI patients

EXPERIMENTAL

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®)

Interventions

LAP-BAND® Adjustable Gastric Band (LAGB®) DEVICE

Bariatric surgery for patient whose BMI is between 30 and 40 kg/m\^2

LAGB for low BMI patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Allergan: collaborator

Related Links

• NYU Program for Surgical Weight Loss

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Heekoung Youn
• Organization: NYULMC

younh01@nyumc.org

2122632174

Study Officials

• Christine Ren-Fielding, M.D.

  NYUSOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research coordinator

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 24, 2007
• Study Start: March 1, 2004
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 23, 2015
• Results First Posted: March 23, 2015

Record last verified: 2015-03