LAGB as a Treatment for Morbid Obesity in Adolescents

Jeffrey L Zitsman, MD

Status: Completed

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

Treatments: Device: Laparoscopic adjustable gastric banding (Allergan Lap Band)

Study type: Interventional

Funder types: Other

Identifiers

NCT01045499

AAAB1759

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

laparoscopic gastric banding

Experimental group

Description:

Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.

Treatment:

Device: Laparoscopic adjustable gastric banding (Allergan Lap Band)