LAGB as a Treatment for Morbid Obesity in Adolescents

Status Completed

Clinical Trial 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.

Clinical Trial Description

Seventy to ninety-eight percent of obese children become obese adults. Comorbidities of obesity such as type II diabetes, fatty liver disease, hyperlipidemia, hypertension, asthma, sleep apnea, and depression are becoming increasing common in adolescents as more adolescents become obese. The only consistently durable and effective weight loss programs for the morbidly obese patients are those that include bariatric surgical procedures. The investigators believe that the best initial bariatric surgical option for adolescents is LAGB because of its low complication rates, adjustability, and reversibility. Obese adolescents ages 14-17 who meet criteria for entry will be enrolled to determine the degree of success of LAGB as measured by % excess weight loss, decreased % body fat, decreased body mass index (BMI), reduction in comorbid conditions, and metabolic parameters (including serum lipids and glucose tolerance) at intervals of 3 months, 6 months, 1 year, then annually for a total of 5 years postoperatively. Eligible patients will have been followed for 6 months by physicians in the Center for Adolescent Bariatric Surgery and: 1) will attended a minimum of 75% of visits and 2) will have failed to lose at least 20% of excess weight. Following evaluation by the team (which will include evaluations by a nutritionist, an endocrinologist, a psychologist/psychiatrist, a pediatric nurse practitioner, and a surgeon) a patient may be offered LAGB. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01045499
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	N/A
Start date	September 13, 2005
Completion date	April 30, 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.