Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Obesity

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00474318

7UM1DK072493-17 (U.S. NIH Grant/Contract)

5UM1DK072493-16 (U.S. NIH Grant/Contract)

5UM1DK095710-10 (U.S. NIH Grant/Contract)

17-0235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: Accepts Healthy Volunteers

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
• Unable to sign Informed Consent/Assent

Trial design

250 participants in 1 patient group

Adolescents with severe obesity

Description:

Adolescents and young adults with severe obesity