NCT00592202

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2004-12-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2008-01-11
• Last updated: 2014-04-02

Locations

1 site across 1 country: United States