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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592202
• Other study ID #: 2004-0732
• Status: Completed
• Phase: N/A
• First received: December 27, 2007
• Last updated: March 31, 2014
• Start date: December 2004
• Est. completion date: February 2013

Study information

• Verified date: March 2014
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
United States	UIMC	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		Every six months
Secondary	Resolution of comorbidities		every six months
Secondary	Assess the status of comorbidities and changes in quality of life scores from baseline.		every six months