Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Adolescent Bariatrics: Assessing Health Benefits and Risks|
- Evaluate the efficacy and safety outcomes of bariatric surgery in adolescents relative to adults, using a prospective, observational cohort design. [ Time Frame: Initially funded in 2006 then refunded with extension to 2016. Completed Enrollment 242 participants by 12/31/11 with final surgery done 2/29/12. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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)
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
|Adolescents with severe obesity|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474318
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|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|