Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01045499
Previous Study | Return to List | Next Study

LAGB as a Treatment for Morbid Obesity in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01045499
Recruitment Status : Completed
First Posted : January 11, 2010
Results First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey L Zitsman, MD, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Obstructive Sleep Apnea Syndrome Metabolic Syndrome Insulin Resistance Nonalcoholic Fatty Liver Disease Device: Laparoscopic adjustable gastric banding (Allergan Lap Band) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents
Actual Study Start Date : September 13, 2005
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : April 30, 2017


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Percentage of Excess Weight Change (EWL) [ Time Frame: Baseline and up to 5 years from start of study. ]
    Weight change evaluated in terms of % excess weight loss (EWL).


Secondary Outcome Measures :
  1. Percentage of Excess BMI Change [ Time Frame: Baseline and up to 5 years from start of study. ]
    Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045499


Locations
Layout table for location information
United States, New York
Morgan Stanley Children's Hospital of NY Presbyterian
New York, New York, United States, 10032
Sponsors and Collaborators
Jeffrey L Zitsman, MD
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey L Zitsman, MD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jeffrey L Zitsman, MD, Professor of Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT01045499    
Other Study ID Numbers: AAAB1759
First Posted: January 11, 2010    Key Record Dates
Results First Posted: April 13, 2020
Last Update Posted: April 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Jeffrey L Zitsman, MD, Columbia University:
adolescent obesity surgery
bariatric surgery
adjustable gastric banding
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Obesity
Metabolic Syndrome
Insulin Resistance
Obesity, Morbid
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases