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

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Device: Placement of an adjustable gastric band

• Registration Number: NCT00592202
• Lead Sponsor: University of Illinois at Chicago

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2008-01-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Placement of an adjustable gastric band	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

Primary Outcome Measures

Name	Time	Method
Weight loss	Every six months

Secondary Outcome Measures

Name	Time	Method
Resolution of comorbidities	every six months
Assess the status of comorbidities and changes in quality of life scores from baseline.	every six months

Trial Locations

Locations (1)

UIMC; 🇺🇸 Chicago, Illinois, United States