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| 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 Texas Children's Hospital University of Washington University of North Dakota East Carolina University Oregon Health and Science University |
| Information provided by: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00474318 |
Purpose
Teen-LABS is using standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.
| Condition |
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Obesity |
| MedlinePlus related topics: | Obesity Obesity in Children Weight Loss Surgery |
| Study Type: | Observational |
| Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Adolescent Bariatrics: Assessing Health Benefits and Risks |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | July 2011 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rosie Miller, RN,CCRC | 513-803-0041 | rosemary.miller@cchmc.org |
| United States, Ohio | |||||
| Cincinnati Children's Hospital Medical Center | Recruiting | ||||
| Cincinnati, Ohio, United States, 45229 | |||||
| Sub-Investigator: Meg Zeller, PhD | |||||
| Principal Investigator: Thomas H Inge, MD, PhD | |||||
| Children's Hospital Medical Center, Cincinnati |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| University of Pittsburgh |
| University of Alabama at Birmingham |
| Texas Children's Hospital |
| University of Washington |
| University of North Dakota |
| East Carolina University |
| Oregon Health and Science University |
| Study Chair: | Thomas H Inge, MD, PhD | Children's Hospital Medical Center, Cincinnati |
| Principal Investigator: | Michael A Helmrath, MD, MS | 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: | Judy A Bean, PhD | Children's Hospital Medical Center, Cincinnati |
| Principal Investigator: | Meg Zeller, PhD | Children's Hospital Medical Center, Cincinnati |
More Information
Study webpage
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Related Info
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Related Info
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Study webpage
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| Study ID Numbers: | CCHMC IRB# 07-01-13, UO-1 DK072493-01A1 |
| First Received: | May 15, 2007 |
| Last Updated: | June 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00474318 |
| Health Authority: | United States: Institutional Review Board |
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