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

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ClinicalTrials.gov Identifier: NCT00592202
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Morbid Obesity Device: Placement of an adjustable gastric band

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents
Study Start Date : December 2004
Primary Completion Date : February 2013
Study Completion Date : February 2013
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Weight loss [ Time Frame: Every six months ]

Secondary Outcome Measures :
  1. Resolution of comorbidities [ Time Frame: every six months ]
  2. Assess the status of comorbidities and changes in quality of life scores from baseline. [ Time Frame: every six months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: March 2014

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

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