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LAGB as a Treatment for Morbid Obesity in Adolescents

NCT01045499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2020-04-13

Study results available
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Summary

Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. We are also evaluating the effects of weight loss after LAGB on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.

Conditions

  • Morbid Obesity
  • Obstructive Sleep Apnea Syndrome
  • Metabolic Syndrome
  • Insulin Resistance
  • Nonalcoholic Fatty Liver Disease

Interventions

DEVICE

Laparoscopic adjustable gastric banding (Allergan Lap Band)

Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.

Sponsors & Collaborators

  • Jeffrey L Zitsman, MD

    lead OTHER

Principal Investigators

  • Jeffrey L Zitsman, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-13
Primary Completion
2016-07-31
Completion
2017-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01045499 on ClinicalTrials.gov