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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: University of Illinois at Chicago

Current Primary Outcome: Weight loss [ Time Frame: Every six months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Resolution of comorbidities [ Time Frame: every six months ]
  • Assess the status of comorbidities and changes in quality of life scores from baseline. [ Time Frame: every six months ]


Original Secondary Outcome:

  • Resolution of comorbidities [ Time Frame: every six months ]
  • Complications [ Time Frame: every six months ]


Information By: University of Illinois at Chicago

Dates:
Date Received: December 27, 2007
Date Started: December 2004
Date Completion:
Last Updated: March 31, 2014
Last Verified: March 2014