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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescents with severe obesity<br>Adolescents and young adults with severe obesity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in body mass index from baseline measurement. | 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%. | Calculated at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years). | 
| Change in number of participants achieving remission from baseline Type II diabetes. | 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. | Determined at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years). | 
| Change in number of participants achieving remission from baseline Hypertension. | 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. | Determined at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Hypoferritinemia. | 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. | Determined at each study time point (i.e., baseline, 6 months, 1 year, and annually thereafter through 10 years). | 
| Number of participants with Hypovitaminosis B12. | 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. | Determined at each study time point (i.e., baseline, 6 months, 1 year, and annually thereafter through 10 years). | 
| Occurrence of Abdominal re-operations. | Abdominal re-operations were identified from the following data collection instruments: Discharge Summary, Post-operative Evaluation, and Healthcare Utilization forms. | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Obesity, Bariatrics, Surgery for Weight Loss, Teen-LABS