Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk (Teen-LABS)
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|ClinicalTrials.gov Identifier: NCT00474318|
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2007
Last Update Posted : September 30, 2020
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Adolescents with severe obesity
Adolescents and young adults with severe obesity
- Percent change in body mass index from baseline measurement. [ Time Frame: Calculated at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years). ]Body mass index is calculated as kilograms divided by height in meters squared. Percent change in body mass index from baseline is calculated as: [(Follow-up BMI - Baseline BMI) /Baseline BMI]*100%.
- Change in number of participants achieving remission from baseline Type II diabetes. [ Time Frame: Determined at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years). ]Among those subjects identified with diabetes (DM) at baseline, remission of DM at each post-operative study time point was defined as: no use of medication for DM, and HbA1c < 6.5%, or, if HbA1c was not available, fasting glucose <126mg/dL. DM at baseline was defined by taking into consideration self-report of prior diagnosis, as well as prior medical records from referring physician, use of DM medications, baseline HbA1c ≥6.5%, fasting glucose ≥126 mg/dL, or oral glucose tolerance results in prior 6 months. Participants reporting having polycystic ovarian syndrome who did not meet laboratory criteria for diabetes and were not taking a DM medication other than metformin were not considered to have DM. Participants who were on metformin at baseline for weight management or for insulin resistance, with no other indication of a prior diagnosis of DM documented and no laboratory findings consistent with the diagnosis of DM were not considered to have DM.
- Change in number of participants achieving remission from baseline Hypertension. [ Time Frame: Determined at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years). ]Among those subjects identified with hypertension (HTN) at baseline, remission of HTN was defined as that no medications for blood pressure (BP) were being used and systolic BP < 140 mmHg and diastolic BP < 90 mmHg. BP was measured at the time of the study visit and use of medications for control of BP was recorded on medication use form (MED). Hypertension was defined in a manner consistent with that used to clinically define hypertension: use of BP medications or systolic BP>140 mmHg or diastolic BP > 90 mmHg.
- Number of participants with Hypoferritinemia. [ Time Frame: Determined at each study time point (i.e., baseline, 6 months, 1 year, and annually thereafter through 10 years). ]Fasting blood specimens were drawn at the preoperative, 6 month, and annual research visits. All laboratory assays were performed by the Northwest Lipid Metabolism and Diabetes Research Laboratories (Seattle, WA). Presence of hypoferritinemia is defined as <10ug/L for females and <20ug/L for males.
- Number of participants with Hypovitaminosis B12. [ Time Frame: Determined at each study time point (i.e., baseline, 6 months, 1 year, and annually thereafter through 10 years). ]Fasting blood specimens were drawn at the preoperative, 6 month, and annual research visits. All laboratory assays were performed by the Northwest Lipid Metabolism and Diabetes Research Laboratories (Seattle, WA). Presence of hypovitaminosis B12 is defined as <145pg/mL.
- Occurrence of Abdominal re-operations. [ Time Frame: Occurrence of abdominal re-operations are identified at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years). ]Abdominal re-operations were identified from the following data collection instruments: Discharge Summary, Post-operative Evaluation, and Healthcare Utilization forms.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474318
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45229|
|Study Chair:||Thomas H Inge, MD, PhD||University of Colorado, Denver|
|Principal Investigator:||Stephanie Sisley, MD||Baylor College of Medicine|
|Principal Investigator:||Mike Chen, MD||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:||Marc Michalsky, MD||Nationwide Children's Hospital Medical Center|
|Principal Investigator:||Michael Helmrath, MD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Changchun Xie, PhD||University of Cincinnati|
|Principal Investigator:||James Mitchell, MD||Sanford Health|