ObesityTeen-LABSNCT00474318
Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk
An observational study of Obesity, run by Ann & Robert H Lurie Children's Hospital of Chicago at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2007to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Adolescents up to age 19
- Approved for bariatric surgery
- Agreement to participate in Teen-LABS Study/ understand and sign Informed Consent/Assent
Who cannot join
- Age 19 or greater
- Unable to sign Informed Consent/Assent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of Cincinnati
Cincinnati, Ohio, 45229
About this study
Official title: Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Adolescents, Obesity, Bariatrics, Surgery for Weight Loss, Teen-LABS
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with severe obesity | Adolescents and young adults with severe obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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.
Measured: Determined at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2024
- Study completionJun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (70)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Thomas H Inge, MD, PhD, Study chair, Ann & Robert H Lurie Children's Hospital of ChicagoStephanie Sisley, MD, Principal investigator, Baylor College of MedicineMike Chen, MD, Principal investigator, University of Alabama at BirminghamAnita P Courcoulas, MD, MPH, Principal investigator, University of Pittsburgh Medical CenterTodd M Jenkins, PhD,MPH, Principal investigator, Children's Hospital Medical Center, CincinnatiMarc Michalsky, MD, Principal investigator, Nationwide Children's HospitalMichael Helmrath, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiChangchun Xie, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474318
- Sponsor's protocol ID
- 17-0235
- Other IDs
- 7UM1DK072493-17, 5UM1DK095710-10, 5UM1DK072493-16
- Acronym
- Teen-LABS
- Status last verified
- Nov 2024
- First submitted
- 15 May 2007
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data uploaded to NIH repository and available from publications
Publications
Chidambaran V, Venkatasubramanian R, Sadhasivam S, Esslinger H, Cox S, Diepstraten J, Fukuda T, Inge T, Knibbe CAJ, Vinks AA. Population pharmacokinetic-pharmacodynamic modeling and dosing simulation of propofol maintenance anesthesia in severely obese adolescents. Paediatr Anaesth. 2015 Sep;25(9):911-923. doi: 10.1111/pan.12684. Epub 2015 May 13.
PubMed 25975390Inge TH, Courcoulas AP, Jenkins TM, Michalsky MP, Helmrath MA, Brandt ML, Harmon CM, Zeller MH, Chen MK, Xanthakos SA, Horlick M, Buncher CR; Teen-LABS Consortium. Weight Loss and Health Status 3 Years after Bariatric Surgery in Adolescents. N Engl J Med. 2016 Jan 14;374(2):113-23. doi: 10.1056/NEJMoa1506699. Epub 2015 Nov 6.
PubMed 26544725Gowey MA, Reiter-Purtill J, Becnel J, Peugh J, Mitchell JE, Zeller MH; TeenView Study Group. Weight-related correlates of psychological dysregulation in adolescent and young adult (AYA) females with severe obesity. Appetite. 2016 Apr 1;99:211-218. doi: 10.1016/j.appet.2016.01.020. Epub 2016 Jan 14.
PubMed 26775646Xanthakos SA, Jenkins TM, Kleiner DE, Boyce TW, Mourya R, Karns R, Brandt ML, Harmon CM, Helmrath MA, Michalsky MP, Courcoulas AP, Zeller MH, Inge TH; Teen-LABS Consortium. High Prevalence of Nonalcoholic Fatty Liver Disease in Adolescents Undergoing Bariatric Surgery. Gastroenterology. 2015 Sep;149(3):623-34.e8. doi: 10.1053/j.gastro.2015.05.039. Epub 2015 May 28.
PubMed 26026390Bout-Tabaku S, Michalsky MP, Jenkins TM, Baughcum A, Zeller MH, Brandt ML, Courcoulas A, Buncher R, Helmrath M, Harmon CM, Chen MK, Inge TH. Musculoskeletal Pain, Self-reported Physical Function, and Quality of Life in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Cohort. JAMA Pediatr. 2015 Jun;169(6):552-9. doi: 10.1001/jamapediatrics.2015.0378.
PubMed 25915190Michalsky MP, Inge TH, Simmons M, Jenkins TM, Buncher R, Helmrath M, Brandt ML, Harmon CM, Courcoulas A, Chen M, Horlick M, Daniels SR, Urbina EM; Teen-LABS Consortium. Cardiovascular Risk Factors in Severely Obese Adolescents: The Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study. JAMA Pediatr. 2015 May;169(5):438-44. doi: 10.1001/jamapediatrics.2014.3690.
PubMed 25730293Zeller MH, Inge TH, Modi AC, Jenkins TM, Michalsky MP, Helmrath M, Courcoulas A, Harmon CM, Rofey D, Baughcum A, Austin H, Price K, Xanthakos SA, Brandt ML, Horlick M, Buncher R; Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Consortium. Severe obesity and comorbid condition impact on the weight-related quality of life of the adolescent patient. J Pediatr. 2015 Mar;166(3):651-9.e4. doi: 10.1016/j.jpeds.2014.11.022. Epub 2014 Dec 30.
PubMed 25556022Butte NF, Brandt ML, Wong WW, Liu Y, Mehta NR, Wilson TA, Adolph AL, Puyau MR, Vohra FA, Shypailo RJ, Zakeri IF. Energetic adaptations persist after bariatric surgery in severely obese adolescents. Obesity (Silver Spring). 2015 Mar;23(3):591-601. doi: 10.1002/oby.20994.
PubMed 25707380Jeffreys RM, Inge TH, Jenkins TM, King WC, Oruc V, Douglas AD, Bray MS. Physical activity monitoring in extremely obese adolescents from the Teen-LABORATORIES study. J Phys Act Health. 2015 Jan;12(1):132-8. doi: 10.1123/jpah.2013-0006. Epub 2014 Sep 10.
PubMed 25205688Xiao N, Jenkins TM, Nehus E, Inge TH, Michalsky MP, Harmon CM, Helmrath MA, Brandt ML, Courcoulas A, Moxey-Mims M, Mitsnefes MM; Teen-LABS Consortium. Kidney function in severely obese adolescents undergoing bariatric surgery. Obesity (Silver Spring). 2014 Nov;22(11):2319-25. doi: 10.1002/oby.20870.
PubMed 25376399Inge TH, Zeller M, Harmon C, Helmrath M, Bean J, Modi A, Horlick M, Kalra M, Xanthakos S, Miller R, Akers R, Courcoulas A. Teen-Longitudinal Assessment of Bariatric Surgery: methodological features of the first prospective multicenter study of adolescent bariatric surgery. J Pediatr Surg. 2007 Nov;42(11):1969-71. doi: 10.1016/j.jpedsurg.2007.08.010. No abstract available.
PubMed 18022459Inge TH, Zeller MH, Jenkins TM, Helmrath M, Brandt ML, Michalsky MP, Harmon CM, Courcoulas A, Horlick M, Xanthakos SA, Dolan L, Mitsnefes M, Barnett SJ, Buncher R; Teen-LABS Consortium. Perioperative outcomes of adolescents undergoing bariatric surgery: the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study. JAMA Pediatr. 2014 Jan;168(1):47-53. doi: 10.1001/jamapediatrics.2013.4296.
PubMed 24189578Hillman JB, Miller RJ, Inge TH. Menstrual concerns and intrauterine contraception among adolescent bariatric surgery patients. J Womens Health (Larchmt). 2011 Apr;20(4):533-8. doi: 10.1089/jwh.2010.2462. Epub 2011 Mar 17.
PubMed 21413894Modi AC, Zeller MH, Xanthakos SA, Jenkins TM, Inge TH. Adherence to vitamin supplementation following adolescent bariatric surgery. Obesity (Silver Spring). 2013 Mar;21(3):E190-5. doi: 10.1002/oby.20031.
PubMed 23404956Sawhney P, Modi AC, Jenkins TM, Zeller MH, Kollar LM, Inge TH, Xanthakos SA. Predictors and outcomes of adolescent bariatric support group attendance. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):773-9. doi: 10.1016/j.soard.2013.03.016. Epub 2013 May 3.
PubMed 23810608
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project
- ClinicalTrials.gov ID
- NCT00474318
- Acronym / sponsor ID
- Teen-LABS / 17-0235
- Conditions
- Obesity
- Keywords
- Adolescents, Obesity, Bariatrics, Surgery for Weight Loss, Teen-LABS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- 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
- Study start
- Mar 2007
- Primary completion
- Jun 2024 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with severe obesity | – | –Adolescents and young adults with severe obesity |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- Adolescents up to age 19
- Approved for bariatric surgery
- Agreement to participate in Teen-LABS Study/ understand and sign Informed Consent/Assent
Key exclusion criteria (2 listed)
- Age 19 or greater
- Unable to sign Informed Consent/Assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 25975390Chidambaran V, Venkatasubramanian R, Sadhasivam S, Esslinger H, Cox S, Diepstraten J, Fukuda T, Inge T, Knibbe CAJ, Vinks AA. Population pharmacokinetic-pharmacodynamic modeling and dosing simulation of propofol maintenance anesthesia in severely obese adolescents. Paediatr Anaesth. 2015 Sep;25(9):911-923. doi: 10.1111/pan.12684. Epub 2015 May 13.
- Background: PubMed 26544725Inge TH, Courcoulas AP, Jenkins TM, Michalsky MP, Helmrath MA, Brandt ML, Harmon CM, Zeller MH, Chen MK, Xanthakos SA, Horlick M, Buncher CR; Teen-LABS Consortium. Weight Loss and Health Status 3 Years after Bariatric Surgery in Adolescents. N Engl J Med. 2016 Jan 14;374(2):113-23. doi: 10.1056/NEJMoa1506699. Epub 2015 Nov 6.
- Background: PubMed 26775646Gowey MA, Reiter-Purtill J, Becnel J, Peugh J, Mitchell JE, Zeller MH; TeenView Study Group. Weight-related correlates of psychological dysregulation in adolescent and young adult (AYA) females with severe obesity. Appetite. 2016 Apr 1;99:211-218. doi: 10.1016/j.appet.2016.01.020. Epub 2016 Jan 14.
- Background: PubMed 26026390Xanthakos SA, Jenkins TM, Kleiner DE, Boyce TW, Mourya R, Karns R, Brandt ML, Harmon CM, Helmrath MA, Michalsky MP, Courcoulas AP, Zeller MH, Inge TH; Teen-LABS Consortium. High Prevalence of Nonalcoholic Fatty Liver Disease in Adolescents Undergoing Bariatric Surgery. Gastroenterology. 2015 Sep;149(3):623-34.e8. doi: 10.1053/j.gastro.2015.05.039. Epub 2015 May 28.
- Background: PubMed 25915190Bout-Tabaku S, Michalsky MP, Jenkins TM, Baughcum A, Zeller MH, Brandt ML, Courcoulas A, Buncher R, Helmrath M, Harmon CM, Chen MK, Inge TH. Musculoskeletal Pain, Self-reported Physical Function, and Quality of Life in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Cohort. JAMA Pediatr. 2015 Jun;169(6):552-9. doi: 10.1001/jamapediatrics.2015.0378.
- Background: PubMed 25730293Michalsky MP, Inge TH, Simmons M, Jenkins TM, Buncher R, Helmrath M, Brandt ML, Harmon CM, Courcoulas A, Chen M, Horlick M, Daniels SR, Urbina EM; Teen-LABS Consortium. Cardiovascular Risk Factors in Severely Obese Adolescents: The Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study. JAMA Pediatr. 2015 May;169(5):438-44. doi: 10.1001/jamapediatrics.2014.3690.
- Background: PubMed 25556022Zeller MH, Inge TH, Modi AC, Jenkins TM, Michalsky MP, Helmrath M, Courcoulas A, Harmon CM, Rofey D, Baughcum A, Austin H, Price K, Xanthakos SA, Brandt ML, Horlick M, Buncher R; Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Consortium. Severe obesity and comorbid condition impact on the weight-related quality of life of the adolescent patient. J Pediatr. 2015 Mar;166(3):651-9.e4. doi: 10.1016/j.jpeds.2014.11.022. Epub 2014 Dec 30.
- Background: PubMed 25707380Butte NF, Brandt ML, Wong WW, Liu Y, Mehta NR, Wilson TA, Adolph AL, Puyau MR, Vohra FA, Shypailo RJ, Zakeri IF. Energetic adaptations persist after bariatric surgery in severely obese adolescents. Obesity (Silver Spring). 2015 Mar;23(3):591-601. doi: 10.1002/oby.20994.
- Background: PubMed 25205688Jeffreys RM, Inge TH, Jenkins TM, King WC, Oruc V, Douglas AD, Bray MS. Physical activity monitoring in extremely obese adolescents from the Teen-LABORATORIES study. J Phys Act Health. 2015 Jan;12(1):132-8. doi: 10.1123/jpah.2013-0006. Epub 2014 Sep 10.
- Background: PubMed 25376399Xiao N, Jenkins TM, Nehus E, Inge TH, Michalsky MP, Harmon CM, Helmrath MA, Brandt ML, Courcoulas A, Moxey-Mims M, Mitsnefes MM; Teen-LABS Consortium. Kidney function in severely obese adolescents undergoing bariatric surgery. Obesity (Silver Spring). 2014 Nov;22(11):2319-25. doi: 10.1002/oby.20870.
- Background: PubMed 18022459Inge TH, Zeller M, Harmon C, Helmrath M, Bean J, Modi A, Horlick M, Kalra M, Xanthakos S, Miller R, Akers R, Courcoulas A. Teen-Longitudinal Assessment of Bariatric Surgery: methodological features of the first prospective multicenter study of adolescent bariatric surgery. J Pediatr Surg. 2007 Nov;42(11):1969-71. doi: 10.1016/j.jpedsurg.2007.08.010. No abstract available.
- Background: PubMed 24189578Inge TH, Zeller MH, Jenkins TM, Helmrath M, Brandt ML, Michalsky MP, Harmon CM, Courcoulas A, Horlick M, Xanthakos SA, Dolan L, Mitsnefes M, Barnett SJ, Buncher R; Teen-LABS Consortium. Perioperative outcomes of adolescents undergoing bariatric surgery: the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study. JAMA Pediatr. 2014 Jan;168(1):47-53. doi: 10.1001/jamapediatrics.2013.4296.
- Individual participant dataSharing planned: Yes. Data uploaded to NIH repository and available from publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas H Inge, MD, PhD study chair
Ann & Robert H Lurie Children's Hospital of Chicago
Stephanie Sisley, MD principal investigator
Baylor College of Medicine
Mike Chen, MD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Ann & Robert H Lurie Children's Hospital of Chicago at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474318, which also lists 70 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.