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Trial record 1 of 1 for:    NCT00474318
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Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk (Teen-LABS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00474318
Recruitment Status : Active, not recruiting
First Posted : May 16, 2007
Last Update Posted : February 9, 2023
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital Medical Center, Cincinnati
University of Pittsburgh Medical Center
University of Alabama at Birmingham
Nationwide Children's Hospital
Baylor College of Medicine
Sanford Health
University of Colorado, Denver
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago

Study Description
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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.

Condition or disease
Obesity

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
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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project
Study Start Date : March 2007
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Adolescents with severe obesity
Adolescents and young adults with severe obesity


Outcome Measures
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Primary Outcome Measures :
  1. 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%.

  2. 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.

  3. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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
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)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescents and young adults who were 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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University of Cincinnati
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital Medical Center, Cincinnati
University of Pittsburgh Medical Center
University of Alabama at Birmingham
Nationwide Children's Hospital
Baylor College of Medicine
Sanford Health
University of Colorado, Denver
Investigators
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Study Chair: Thomas H Inge, MD, PhD Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: Stephanie Sisley, MD Baylor College of Medicine
Principal Investigator: Mike Chen, MD University of Alabama at Birmingham
Principal Investigator: Anita P Courcoulas, MD, MPH University of Pittsburgh Medical Center
Principal Investigator: Todd M Jenkins, PhD,MPH Children's Hospital Medical Center, Cincinnati
Principal Investigator: Marc Michalsky, MD Nationwide Children's Hospital
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
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT00474318    
Other Study ID Numbers: 17-0235
7UM1DK072493-17 ( U.S. NIH Grant/Contract )
5UM1DK095710-10 ( U.S. NIH Grant/Contract )
5UM1DK072493-16 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data uploaded to NIH repository and available from publications
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Adolescents
Obesity
Bariatrics
Surgery for Weight Loss
Teen-LABS
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight