search
Back to results

LAGB as a Treatment for Morbid Obesity in Adolescents

Primary Purpose

Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic adjustable gastric banding (Allergan Lap Band)
Sponsored by
Jeffrey L Zitsman, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring adolescent obesity surgery, bariatric surgery, adjustable gastric banding

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Morgan Stanley Children's Hospital of NY Presbyterian

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

laparoscopic gastric banding

Arm Description

Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.

Outcomes

Primary Outcome Measures

Percentage of Excess Weight Change (EWL)
Weight change evaluated in terms of % excess weight loss (EWL).

Secondary Outcome Measures

Percentage of Excess BMI Change
Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).

Full Information

First Posted
January 7, 2010
Last Updated
April 1, 2020
Sponsor
Jeffrey L Zitsman, MD
search

1. Study Identification

Unique Protocol Identification Number
NCT01045499
Brief Title
LAGB as a Treatment for Morbid Obesity in Adolescents
Official Title
Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 13, 2005 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey L Zitsman, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance, Nonalcoholic Fatty Liver Disease
Keywords
adolescent obesity surgery, bariatric surgery, adjustable gastric banding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic gastric banding
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Laparoscopic adjustable gastric banding (Allergan Lap Band)
Other Intervention Name(s)
LAP-BAND®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Excess Weight Change (EWL)
Description
Weight change evaluated in terms of % excess weight loss (EWL).
Time Frame
Baseline and up to 5 years from start of study.
Secondary Outcome Measure Information:
Title
Percentage of Excess BMI Change
Description
Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).
Time Frame
Baseline and up to 5 years from start of study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Zitsman, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morgan Stanley Children's Hospital of NY Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23140654
Citation
Sysko R, Devlin MJ, Hildebrandt TB, Brewer SK, Zitsman JL, Walsh BT. Psychological outcomes and predictors of initial weight loss outcomes among severely obese adolescents receiving laparoscopic adjustable gastric banding. J Clin Psychiatry. 2012 Oct;73(10):1351-7. doi: 10.4088/JCP.12m07690.
Results Reference
derived
PubMed Identifier
21299450
Citation
Sysko R, Zakarin EB, Devlin MJ, Bush J, Walsh BT. A latent class analysis of psychiatric symptoms among 125 adolescents in a bariatric surgery program. Int J Pediatr Obes. 2011 Aug;6(3-4):289-97. doi: 10.3109/17477166.2010.545411. Epub 2011 Feb 8.
Results Reference
derived

Learn more about this trial

LAGB as a Treatment for Morbid Obesity in Adolescents

We'll reach out to this number within 24 hrs