LAGB as a Treatment for Morbid Obesity in Adolescents

Completed · Not applicable

Conditions studied: Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance, Nonalcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT01045499

Run by

Jeffrey L Zitsman, MD

People needed

137

Starts

2005-09-13

Expected to finish

2017-04-30

Last updated by the study team

2020-04-13

Who can join

Age: 13 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 13-17 upon entry
• BMI >40 or >35 with associated medical comorbidities (e.g., sleep apnea, hypertension

You may not qualify if…

• severe psychiatric illness
• eating disorder with purging
• previous weight loss surgery
• stated inability to comply with pre-op and post-op visits

Where it is running

• Morgan Stanley Children's Hospital of NY Presbyterian — New York, New York, United States

Full record on ClinicalTrials.gov

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