NCT01045499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2005

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

March 1, 2020

Enrollment Period

10.9 years

First QC Date

January 7, 2010

Results QC Date

March 17, 2020

Last Update Submit

April 1, 2020

Conditions

Morbid ObesityObstructive Sleep Apnea SyndromeMetabolic SyndromeInsulin ResistanceNonalcoholic Fatty Liver Disease

Keywords

adolescent obesity surgerybariatric surgeryadjustable gastric banding

Outcome Measures

Primary Outcomes (1)

  • Percentage of Excess Weight Change (EWL)

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

    Baseline and up to 5 years from start of study.

Secondary Outcomes (1)

  • Percentage of Excess BMI Change

    Baseline and up to 5 years from start of study.

Study Arms (1)

laparoscopic gastric banding

EXPERIMENTAL

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)

Interventions

Laparoscopic adjustable gastric banding (Allergan Lap Band)DEVICE

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.

Also known as: LAP-BAND®
laparoscopic gastric banding

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 13-17 upon entry
  • BMI \>40 or \>35 with associated medical comorbidities (e.g., sleep apnea, hypertension

You may not qualify if:

  • severe psychiatric illness
  • eating disorder with purging
  • previous weight loss surgery
  • stated inability to comply with pre-op and post-op visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morgan Stanley Children's Hospital of NY Presbyterian

New York, New York, 10032, United States

Location

Related Publications (2)

  • 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.

    PMID: 23140654DERIVED

  • 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.

    PMID: 21299450DERIVED

MeSH Terms

Conditions

Obesity, MorbidSleep Apnea, ObstructiveMetabolic SyndromeInsulin ResistanceNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Jeffrey Zitsman, MD
Organization
Columbia University
jlz2@cumc.columbia.edu
212-305-8862

Study Officials

  • Jeffrey L Zitsman, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 11, 2010

Study Start

September 13, 2005

Primary Completion

July 31, 2016

Study Completion

April 30, 2017

Last Updated

April 13, 2020

Results First Posted

April 13, 2020

Record last verified: 2020-03

Locations

US(1)