Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk - Tabular View

Tracking Information

First Received Date ^ICMJE

May 15, 2007

Last Updated Date

November 19, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00474318 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk

Official Title ^ICMJE

Adolescent Bariatrics: Assessing Health Benefits and Risks

Brief Summary

Teen-LABS is using standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.

Detailed Description

The goal of Teen-LABS is to facilitate coordinated clinical, epidemiological and behavioral research in the field of adolescent bariatric surgery, through the cooperative development of common clinical protocols and a bariatric surgery database that will collect information from participating clinical centers performing bariatric surgery on teenagers.

Teen-LABS will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple clinical studies in a timely, efficient manner. Also, the use of standardized definitions, shared clinical protocols and data-collection instruments will enhance investigators' ability to provide meaningful evidence-based recommendations for patient evaluation, selection and follow-up care.

In addition to investigating surgical outcomes, another broader goal of Teen-LABS is to better understand the etiology, pathophysiology, and behavioral aspects of severe obesity in youth and how this condition affects human beings over time.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other, Prospective

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Study Arms / Comparison Groups

Adult Cohort of subjects participating at several LABS sites.

Publications *

Inge TH, Zeller M, Harmon C, Helmrath M, Bean J, Modi A, Horlick M, Kalra M, Xanthakos S, Miller R, Akers R, Courcoulas A. Teen-Longitudinal Assessment of Bariatric Surgery: methodological features of the first prospective multicenter study of adolescent bariatric surgery. J Pediatr Surg. 2007 Nov;42(11):1969-71. No abstract available.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

July 2011

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adolescents up to age 19
Approved for Bariatric Surgery
Agreement to participate in Teen-LABS Study/ understand and sign Informed Consent/Assent

Exclusion Criteria:

Age 19 or greater
Not Approved for Bariatric Surgery
Unable to sign Informed Consent/Assent

Gender

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rosie Miller, RN,CCRC

513-803-0041

rosemary.miller@cchmc.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00474318

Responsible Party

Thomas H. Inge, MD, PhD, Cincinnati Children's Hospital Medical Center

Study ID Numbers ^ICMJE

CCHMC IRB# 2008-1634, UO-1 DK072493-01A1

Study Sponsor ^ICMJE

Children's Hospital Medical Center, Cincinnati

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh
University of Alabama at Birmingham
Nationwide Children's Hospital
Texas Children's Hospital
University of Washington
University of North Dakota
East Carolina University
Oregon Health and Science University

Investigators ^ICMJE

Study Chair:	Thomas H Inge, MD, PhD	Children's Hospital Medical Center, Cincinnati
Principal Investigator:	Mary L Brandt, MD	Texas Childrens Hospital Medical Center
Principal Investigator:	Carroll M Harmon, MD, PhD	Children's Hospital of Alabama
Principal Investigator:	Anita P Courcoulas, MD, MPH	University of Pittsburgh
Principal Investigator:	Todd M Jenkins, PhD,MPH	Children's Hospital Medical Center, Cincinnati
Principal Investigator:	Meg Zeller, PhD	Children's Hospital Medical Center, Cincinnati
Principal Investigator:	Marc Mikalsky, MD	Nationwide Children's Hospital Medical Center
Principal Investigator:	Michael Helmrath, MD	University of North Carolina

Information Provided By

Children's Hospital Medical Center, Cincinnati

Verification Date

October 2008

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