Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk (Teen-LABS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00474318|
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2007
Last Update Posted : August 23, 2017
|Condition or disease|
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.
In the 3rd five year cycle of funding for this project, several additional long-term research aims have been added, all in general alignment with the original aims of the project to assess efficacy and safety of bariatric surgery performed in adolescent years.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Adolescents with severe obesity
Adolescents and young adults with severe obesity
- 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 2021. ]Enrolled 242 participants by 12/31/11. Continued participation of initial cohort with additional participants with specified conditions to enroll between 2017-2021. To compare risks and benefits of gastric bypass and sleeve gastrectomy procedures in individuals undergoing these procedures as adolescents.
- Assessment of long term safety by assessment of bone mineral density, micronutrient status, and continued collection of detailed data characterizing pregnancies, childbirth, abdominal operations, and deaths. [ Time Frame: 2016-2021 ]To identify complications to be expected for adolescents and adults undergoing bariatric surgery, specifically short and long-term surgical, medical and nutritional bone density, and risk taking behaviors.
- Exploratory Aim 3: To document psychosocial status, cognitive functio0n, and behavioral constructs in those individuals who undergo bariatric surgery as adolescents. [ Time Frame: 2016-2021 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474318
|United States, Colorado|
|University of Colorado Denver|
|Denver, Colorado, United States|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45229|
|Study Chair:||Thomas H Inge, MD, PhD||University of Colorado, Denver|
|Principal Investigator:||Mary L Brandt, MD||Texas Childrens Hospital Medical Center|
|Principal Investigator:||Mike Chen, MD||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:||Marc Michalsky, MD||Nationwide Children's Hospital Medical Center|
|Principal Investigator:||Michael Helmrath, MD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Changchun Xie, PhD||University of Cincinnati|
|Principal Investigator:||James Mitchell, MD||Neuropsychiatric Research Institute|