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

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

Detailed Description
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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.

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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: Placement of an adjustable gastric band


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Device: Placement of an adjustable gastric band<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | Every six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of comorbidities |  | every six months | 
| Assess the status of comorbidities and changes in quality of life scores from baseline. |  | every six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid obesity, Adolescents, Gastric restrictive procedure, Adjustable gastric band, Treatment