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:
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
  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: Time Perspective: Prospective
Official Title: Adolescent Bariatrics: Assessing Health Benefits and Risks

Resource links provided by NLM:


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

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: June 2016
Groups/Cohorts
Adolescents 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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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 19 or greater
  • Not approved for bariatric surgery
  • Unable to sign Informed Consent/Assent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474318

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
University of Pittsburgh
University of Alabama at Birmingham
Nationwide Children's Hospital
Texas Children's Hospital
University of Washington
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00474318     History of Changes
Other Study ID Numbers: CCHMC IRB# 2008-1634, 2UM1DK072493-06
Study First Received: May 15, 2007
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014