Clinical trial NCT01045499: LAGB as a Treatment for Morbid Obesity in Adolescents
Official title: Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Obstructive Sleep Apnea Syndrome
Metabolic Syndrome
Insulin Resistance
Nonalcoholic Fatty Liver Disease
Keywords: adolescent obesity surgery
bariatric surgery
adjustable gastric banding
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 137
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Excess Weight Change (EWL)
timeFrame: Baseline and up to 5 years from start of study.
Secondary outcomes:
measure: Percentage of Excess BMI Change
timeFrame: Baseline and up to 5 years from start of study.
Other outcomes:
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital of NY Presbyterian
state: New York
Study officials:
affiliation: Columbia University
name: Jeffrey L Zitsman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sysko R, Devlin MJ, Hildebrandt TB, Brewer SK, Zitsman JL, Walsh BT. Psychological outcomes and predictors of initial weight loss outcomes among severely obese adolescents receiving laparoscopic adjustable gastric banding. J Clin Psychiatry. 2012 Oct;73(10):1351-7. doi: 10.4088/JCP.12m07690.
citation: Sysko R, Zakarin EB, Devlin MJ, Bush J, Walsh BT. A latent class analysis of psychiatric symptoms among 125 adolescents in a bariatric surgery program. Int J Pediatr Obes. 2011 Aug;6(3-4):289-97. doi: 10.3109/17477166.2010.545411. Epub 2011 Feb 8.