Morbid Obesity
Conditions
Keywords
Morbid obesity, Adolescents, Gastric restrictive procedure, Adjustable gastric band, Treatment
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.
Interventions
DEVICEPlacement 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.
Sponsors
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss | Every six months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed