LAGB as a Treatment for Morbid Obesity in Adolescents
Condition: Morbid Obesity; Obstructive Sleep Apnea Syndrome; Metabolic Syndrome; Insulin Resistance; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Obesity; Metabolic Syndrome; Insulin Resistance; Obesity, Morbid; Syndrome
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Laparoscopic adjustable gastric banding (Allergan Lap Band)
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): LAP-BAND®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adolescent obesity surgery; bariatric surgery; adjustable gastric banding