Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Morbid Obesity Obstructive Sleep Apnea Syndrome Metabolic Syndrome Insulin Resistance Nonalcoholic Fatty Liver Disease |
Device: Laparoscopic adjustable gastric banding (Allergan Lap Band System) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | LAGB Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents |
- The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL). [ Time Frame: Up to 5 years from start of study. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 125 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | June 2016 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
-
Device: Laparoscopic adjustable gastric banding (Allergan Lap Band System)
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 the LAPBAND® procedure 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 LAPBAND® 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 LAPBAND®.
Eligibility| Ages Eligible for Study: | 14 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 14-17 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
Contacts and Locations| United States, New York | |
| Morgan Stnaley Children's Hospital of NY Presbyterian | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Jeffrey L Zitsman, MD | Columbia University College of Physicians and Surgeons |
More Information
No publications provided by Columbia University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeffrey L Zitsman, MD, Associate Clinical Professor, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01045499 History of Changes |
| Other Study ID Numbers: | AAAB1759 |
| Study First Received: | January 7, 2010 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Columbia University:
|
adolescent obesity surgery bariatric surgery adjustable gastric banding |
Additional relevant MeSH terms:
|
Fatty Liver Insulin Resistance Liver Diseases Obesity Obesity, Morbid Sleep Apnea Syndromes Sleep Apnea, Obstructive Metabolic Syndrome X Digestive System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013