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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:
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
ClinicalTrials.gov Identifier:
NCT00474318
First received: May 15, 2007
Last updated: August 21, 2017
Last verified: August 2017
  Purpose
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.

Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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)

Estimated Enrollment: 200
Study Start Date: March 2007
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adolescents with severe obesity
Adolescents and young adults with severe obesity

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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474318

Locations
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
Sponsors and Collaborators
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
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00474318     History of Changes
Other Study ID Numbers: 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 )
Study First Received: May 15, 2007
Last Updated: August 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data uploaded to NIH repository and available from publications

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Adolescents
Obesity
Bariatrics
Surgery for Weight Loss
Teen-LABS

ClinicalTrials.gov processed this record on September 21, 2017