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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bob Kanard, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00592202
First received: December 27, 2007
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Morbid Obesity
Device: Placement of an adjustable gastric band

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Weight loss [ Time Frame: Every six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resolution of comorbidities [ Time Frame: every six months ] [ Designated as safety issue: No ]
  • Assess the status of comorbidities and changes in quality of life scores from baseline. [ Time Frame: every six months ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: December 2004
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592202

Locations
United States, Illinois
UIMC
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Robert Kanard, M.D. Division of Pediatric Surgery, UIC
  More Information

No publications provided

Responsible Party: Bob Kanard, Visiting Assistant Professor/MD, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00592202     History of Changes
Other Study ID Numbers: 2004-0732
Study First Received: December 27, 2007
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois at Chicago:
Morbid obesity
Adolescents
Gastric restrictive procedure
Adjustable gastric band
Treatment

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014