LAGB as a Treatment for Morbid Obesity in Adolescents

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045499
• Other study ID #: AAAB1759
• Status: Completed
• Phase: N/A
• Start date: September 13, 2005
• Est. completion date: April 30, 2017

Study information

• Verified date: March 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: April 30, 2017
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Insulin Resistance
• Liver Diseases
• Metabolic Syndrome
• Morbid Obesity
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Obesity
• Obesity, Morbid
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• Laparoscopic adjustable gastric banding (Allergan Lap Band)
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.

Locations

Country	Name	City	State
United States	Morgan Stanley Children's Hospital of NY Presbyterian	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey L Zitsman, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Excess Weight Change (EWL)	Weight change evaluated in terms of % excess weight loss (EWL).	Baseline and up to 5 years from start of study.
Secondary	Percentage of Excess BMI Change	Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).	Baseline and up to 5 years from start of study.