This trial is active, not recruiting.

Condition obesity
Sponsor Children's Hospital Medical Center, Cincinnati
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date March 2007
End date August 2016
Trial size 200 participants
Trial identifier NCT00474318, 2UM1DK072493-06, CCHMC IRB# 2008-1634


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

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.

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

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

Additional Information

Official title Adolescent Bariatrics: Assessing Health Benefits and Risks
Principal investigator Mary L Brandt, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.