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| Sponsor: | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Collaborators: |
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 |
| Information provided by (Responsible Party): | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00474318 |
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 |
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 |
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 | |
| 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
| 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: | November 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Adolescents Obesity Bariatrics Surgery for Weight Loss Teen-LABS |
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
