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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey L Zitsman, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01045499
First received: January 7, 2010
Last updated: February 5, 2014
Last verified: February 2014
  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)
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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)
Arms Assigned Interventions
Experimental: laparoscopic gastric banding
Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.
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.
Other Name: LAP-BAND®

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

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01045499

Locations
United States, New York
Morgan Stnaley Children's Hospital of NY Presbyterian
New York, New York, United States, 10032
Sponsors and Collaborators
Jeffrey L Zitsman, MD
Investigators
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: February 5, 2014
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 July 20, 2014