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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00474318
First received: May 15, 2007
Last updated: June 1, 2012
Last verified: June 2012
History of Changes

May 15, 2007
June 1, 2012
March 2007
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Complete list of historical versions of study NCT00474318 on ClinicalTrials.gov Archive Site
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Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk
Adolescent Bariatrics: Assessing Health Benefits and Risks

The five Teen-LABS clinical centers use standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.

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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, plasma and urine, as well as liver samples (if agreed upon as part of the study; may participate in the study without giving samples per Informed Consent)
Non-Probability Sample

Adolescents who are approved to undergo bariatriac surgery, at a participating study site, by a Teen-LABS approved surgeon, that have signed Informed Consent to participate in the study
Obesity
Not Provided
Adolescents with severe obesity
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2016
Not Provided

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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00474318
CCHMC IRB# 2008-1634, 2UM1DK072493-06
Yes
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
  • 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
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 Michalsky, MD Nationwide Children's Hospital Medical Center
Principal Investigator: Michael Helmrath, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Ralph Buncher, ScD Cincinnati Children's Hospital Medical Center Data Coordinating Center
Children's Hospital Medical Center, Cincinnati
June 2012

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