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Trial record 1 of 1 for:    NCT00474318
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Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk (Teen-LABS)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00474318
First Posted: May 16, 2007
Last Update Posted: August 23, 2017
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.
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
Neuropsychiatric Research Institute, Fargo, North Dakota
University of Colorado, Denver
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
May 15, 2007
May 16, 2007
August 23, 2017
March 2007
August 2021   (Final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00474318 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk
Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project
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.

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.

Observational
Observational Model: Other
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 and young adults who were 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
Adolescents and young adults with severe obesity

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
August 2021
August 2021   (Final data collection date for primary outcome measure)

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 29 or greater
  • Unable to sign Informed Consent/Assent
Sexes Eligible for Study: All
12 Years to 28 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00474318
CCHMC IRB# 2016-9583
2UM1DK072493-11 ( U.S. NIH Grant/Contract )
2UM1DK095710-06 ( U.S. NIH Grant/Contract )
7UM1DK072493-12 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Data uploaded to NIH repository and available from publications
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
  • Neuropsychiatric Research Institute, Fargo, North Dakota
  • University of Colorado, Denver
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
Children's Hospital Medical Center, Cincinnati
August 2017