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

University of Illinois

Status: Completed

Conditions: Morbid Obesity

Treatments: Device: Placement of an adjustable gastric band

Study type: Interventional

Funder types: Other

Identifiers

NCT00592202

2004-0732

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 14 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Device: Placement of an adjustable gastric band