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NCT Number: NCT01045499

LAGB as a Treatment for Morbid Obesity in Adolescents

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Laparoscopic adjustable gastric banding (Allergan Lap Band)

Device

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.

Other names: LAP-BAND®

Primary outcomes

  1. Percentage of Excess Weight Change (EWL)

    Time frame: Baseline and up to 5 years from start of study.

    Weight change evaluated in terms of % excess weight loss (EWL).

Secondary outcomes

  1. Percentage of Excess BMI Change

    Time frame: Baseline and up to 5 years from start of study.

    Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).

Sponsors and collaborators

Lead sponsor

Jeffrey L Zitsman, MD

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2016
Study completion
2017
First posted
Jan 11, 2010
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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