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LAGB as a Treatment for Morbid Obesity in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey L Zitsman, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01045499
First received: January 7, 2010
Last updated: February 10, 2017
Last verified: February 2017
January 7, 2010
February 10, 2017
September 13, 2005
July 31, 2016   (Final data collection date for primary outcome measure)
Percentage of excess weight loss (EWL) [ Time Frame: Up to 5 years from start of study. ]
The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL).
The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL). [ Time Frame: Weight will be measured post-operatively at 2 weeks, 6 weeks, 3 months and monthly thereafter for the initial 12 months, then at 15 months, 18 months, and 6 months thereafter to complete the five years. ]
Complete list of historical versions of study NCT01045499 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
LAGB as a Treatment for Morbid Obesity in Adolescents
Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Morbid Obesity
  • Obstructive Sleep Apnea Syndrome
  • Metabolic Syndrome
  • Insulin Resistance
  • Nonalcoholic Fatty Liver Disease
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®
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.
Intervention: Device: Laparoscopic adjustable gastric banding (Allergan Lap Band)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
July 31, 2016
July 31, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years to 19 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01045499
AAAB1759
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: Undecided
Jeffrey L Zitsman, MD, Columbia University
Jeffrey L Zitsman, MD
Not Provided
Principal Investigator: Jeffrey L Zitsman, MD Columbia University
Columbia University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP