Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents

NCT ID: NCT00592202

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2013-02-28

Brief Summary

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

Detailed Description

The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.

Conditions

Morbid Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Adolescents between the ages 14 through 17 with a BMI of 40 or more or with a BMI of 35 or more and with an obesity related comorbidity will undergo placement of an adjustable gastric band

Group Type: EXPERIMENTAL

Placement of an adjustable gastric band

Intervention Type: DEVICE

Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.

Interventions

Placement of an adjustable gastric band

Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ages 14 through 17
• BMI greater than 40
• BMI 35 to 40 and also having an obesity related comorbidity
• Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training

Exclusion Criteria

• Subject history of congenital or acquired anomalies fo the gastrointestinal tract
• Severe cardiopulmonary or other serious organic disease
• Severe coagulopathy
• Hepatic insufficiency or cirrhosis
• History of bariatric gastric or esophageal surgery
• History of intestinal obstruction or adhesive peritonitis
• History of esophageal motility disorders
• Type I diabetes

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Bob Kanard

Visiting Assistant Professor/MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Kanard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Pediatric Surgery, UIC

Locations

UIMC

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2004-0732

Identifier Type: -

Identifier Source: org_study_id