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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 Nationwide Children's Hospital Texas Children's Hospital University of Washington University of North Dakota East Carolina University Oregon Health and Science University |
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| 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 |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Adolescent Bariatrics: Assessing Health Benefits and Risks |
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: | July 2011 |
| Groups/Cohorts |
|---|
|
Adult Cohort
Adult Cohort of subjects participating at several LABS sites.
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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 |
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.
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 | |
| 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: | Jimmy Efird, PhD | Children's Hospital Medical Center, Cincinnati |
| Principal Investigator: | Meg Zeller, PhD | Children's Hospital Medical Center, Cincinnati |
| Principal Investigator: | Marc Mikalsky, MD | Nationwide Children's Hospital Medical Center |
| Principal Investigator: | Michael Helmrath, MD | University of North Carolina |
More Information
| Responsible Party: | Cincinnati Children's Hospital Medical Center ( Thomas H. Inge, MD, PhD ) |
| Study ID Numbers: | CCHMC IRB# 07-01-13, UO-1 DK072493-01A1 |
| Study First Received: | May 15, 2007 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00474318 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Adolescents Obesity Bariatrics Surgery for Weight Loss Teen-LABS |
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Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition |
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Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
