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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00592202
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Bob Kanard, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE December 27, 2007
First Posted Date  ICMJE January 11, 2008
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE December 2004
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
Weight loss [ Time Frame: Every six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00592202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
  • 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 Measures  ICMJE
 (submitted: December 27, 2007)
  • Resolution of comorbidities [ Time Frame: every six months ]
  • Complications [ Time Frame: every six months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Device: Placement of an adjustable gastric band
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2014)
37
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2007)
50
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00592202
Other Study ID Numbers  ICMJE 2004-0732
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bob Kanard, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Kanard, M.D. Division of Pediatric Surgery, UIC
PRS Account University of Illinois at Chicago
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP