Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 3
- Primary Endpoint
- Percent change in body mass index from baseline measurement.
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of participants with Hypoferritinemia.(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.(Determined at each study time point (i.e., baseline, 6 months, 1 year, and annually thereafter through 10 years).)
- Occurrence of Abdominal re-operations.(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).)