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

Overview

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.

Full Title of Study: “Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2021

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.

Arms, Groups and Cohorts

  • Adolescents with severe obesity
    • Adolescents and young adults with severe obesity

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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 29 or greater
  • Unable to sign Informed Consent/Assent

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 28 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Collaborator
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas H Inge, MD, PhD, Study Chair, University of Colorado, Denver
    • Mary L Brandt, MD, Principal Investigator, Texas Childrens Hospital Medical Center
    • Mike Chen, MD, Principal Investigator, Children’s Hospital of Alabama
    • Anita P Courcoulas, MD, MPH, Principal Investigator, University of Pittsburgh
    • Todd M Jenkins, PhD,MPH, Principal Investigator, Children’s Hospital Medical Center, Cincinnati
    • Marc Michalsky, MD, Principal Investigator, Nationwide Children’s Hospital Medical Center
    • Michael Helmrath, MD, Principal Investigator, Children’s Hospital Medical Center, Cincinnati
    • Changchun Xie, PhD, Principal Investigator, University of Cincinnati
    • James Mitchell, MD, Principal Investigator, Sanford Health

References

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.

Inge 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.

Gowey 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.

Xanthakos 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.

Bout-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.

Michalsky 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.

Zeller 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.

Butte 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.

Jeffreys 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.

Xiao 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.

Inge 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.

Inge 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.

Hillman 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.

Modi 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.

Sawhney 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.

Jenkins TM, Wilson Boyce T, Akers R, Andringa J, Liu Y, Miller R, Powers C, Ralph Buncher C. Evaluation of a Teleform-based data collection system: a multi-center obesity research case study. Comput Biol Med. 2014 Jun;49:15-8. doi: 10.1016/j.compbiomed.2014.03.002. Epub 2014 Mar 13.

Michalsky MP, Raman SV, Teich S, Schuster DP, Bauer JA. Cardiovascular recovery following bariatric surgery in extremely obese adolescents: preliminary results using Cardiac Magnetic Resonance (CMR) Imaging. J Pediatr Surg. 2013 Jan;48(1):170-7. doi: 10.1016/j.jpedsurg.2012.10.032.

Chuang J, Zeller MH, Inge T, Crimmins N. Bariatric surgery for severe obesity in two adolescents with type 1 diabetes. Pediatrics. 2013 Oct;132(4):e1031-4. doi: 10.1542/peds.2012-3640. Epub 2013 Sep 23.

Kaulfers AM, Bean JA, Inge TH, Dolan LM, Kalkwarf HJ. Bone loss in adolescents after bariatric surgery. Pediatrics. 2011 Apr;127(4):e956-61. doi: 10.1542/peds.2010-0785. Epub 2011 Mar 28.

Inge TH, King WC, Jenkins TM, Courcoulas AP, Mitsnefes M, Flum DR, Wolfe BM, Pomp A, Dakin GF, Khandelwal S, Zeller MH, Horlick M, Pender JR, Chen JY, Daniels SR. The effect of obesity in adolescence on adult health status. Pediatrics. 2013 Dec;132(6):1098-104. doi: 10.1542/peds.2013-2185. Epub 2013 Nov 18.

Michalsky MP, Inge TH, Teich S, Eneli I, Miller R, Brandt ML, Helmrath M, Harmon CM, Zeller MH, Jenkins TM, Courcoulas A, Buncher RC; Teen-LABS Consortium. Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience. Semin Pediatr Surg. 2014 Feb;23(1):5-10. doi: 10.1053/j.sempedsurg.2013.10.020. Epub 2013 Oct 31.

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Diepstraten J, Chidambaran V, Sadhasivam S, Esslinger HR, Cox SL, Inge TH, Knibbe CA, Vinks AA. Propofol clearance in morbidly obese children and adolescents: influence of age and body size. Clin Pharmacokinet. 2012 Aug 1;51(8):543-51. doi: 10.2165/11632940-000000000-00000.

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Diepstraten J, Chidambaran V, Sadhasivam S, Blussé van Oud-Alblas HJ, Inge T, van Ramshorst B, van Dongen EP, Vinks AA, Knibbe CA. An integrated population pharmacokinetic meta-analysis of propofol in morbidly obese and nonobese adults, adolescents, and children. CPT Pharmacometrics Syst Pharmacol. 2013 Sep 11;2:e73. doi: 10.1038/psp.2013.47.

Ratcliff MB, Zeller MH, Inge TH, Hrovat KB, Modi AC. Feasibility of ecological momentary assessment to characterize adolescent postoperative diet and activity patterns after weight loss surgery. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):705-10. doi: 10.1016/j.soard.2014.01.034. Epub 2014 Feb 12.

Zeller MH, Noll JG, Sarwer DB, Reiter-Purtill J, Rofey DL, Baughcum AE, Peugh J, Courcoulas AP, Michalsky MP, Jenkins TM, Becnel JN; TeenView Study Group and in Cooperation With Teen-LABS Consortium. Child Maltreatment and the Adolescent Patient With Severe Obesity: Implications for Clinical Care. J Pediatr Psychol. 2015 Aug;40(7):640-8. doi: 10.1093/jpepsy/jsv011. Epub 2015 Mar 15.

Utzinger LM, Gowey MA, Zeller M, Jenkins TM, Engel SG, Rofey DL, Inge TH, Mitchell JE; Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Consortium. Loss of control eating and eating disorders in adolescents before bariatric surgery. Int J Eat Disord. 2016 Oct;49(10):947-952. doi: 10.1002/eat.22546. Epub 2016 May 19.

Zani A, Ford-Adams M, Ratcliff M, Bevan D, Inge TH, Desai A. Weight loss surgery improves quality of life in pediatric patients with osteogenesis imperfecta. Surg Obes Relat Dis. 2017 Jan;13(1):41-44. doi: 10.1016/j.soard.2015.11.029. Epub 2015 Dec 2.

Xiao N, Devarajan P, Inge TH, Jenkins TM, Bennett M, Mitsnefes MM. Subclinical kidney injury before and 1 year after bariatric surgery among adolescents with severe obesity. Obesity (Silver Spring). 2015 Jun;23(6):1234-8. doi: 10.1002/oby.21070. Epub 2015 May 9.

Rofey DL, Zeller MH, Brode C, Reiter-Purtill J, Mikhail C, Washington G, Baughcum AE, Peugh J, Austin H, Jenkins TM, Courcoulas AP; TeenView Writing Group in cooperation with the Teen-LABS Consortium. A multisite view of psychosocial risks in patients presenting for bariatric surgery. Obesity (Silver Spring). 2015 Jun;23(6):1218-25. doi: 10.1002/oby.21065. Epub 2015 May 9.

DeFoor WR, Asplin JR, Kollar L, Jackson E, Jenkins T, Schulte M, Inge T. Prospective evaluation of urinary metabolic indices in severely obese adolescents after weight loss surgery. Surg Obes Relat Dis. 2016 Feb;12(2):363-7. doi: 10.1016/j.soard.2015.03.013. Epub 2015 Mar 28.

Kelly AS, Ryder JR, Marlatt KL, Rudser KD, Jenkins T, Inge TH. Changes in inflammation, oxidative stress and adipokines following bariatric surgery among adolescents with severe obesity. Int J Obes (Lond). 2016 Feb;40(2):275-80. doi: 10.1038/ijo.2015.174. Epub 2015 Aug 28.

Zeller MH, Washington GA, Mitchell JE, Sarwer DB, Reiter-Purtill J, Jenkins TM, Courcoulas AP, Peugh JL, Michalsky MP, Inge TH; Teen-LABS Consortium and in collaboration with the TeenView Study Group. Alcohol use risk in adolescents 2 years after bariatric surgery. Surg Obes Relat Dis. 2017 Jan;13(1):85-94. doi: 10.1016/j.soard.2016.05.019. Epub 2016 May 25.

Ryder JR, Edwards NM, Gupta R, Khoury J, Jenkins TM, Bout-Tabaku S, Michalsky MP, Harmon CM, Inge TH, Kelly AS. Changes in Functional Mobility and Musculoskeletal Pain After Bariatric Surgery in Teens With Severe Obesity: Teen-Longitudinal Assessment of Bariatric Surgery (LABS) Study. JAMA Pediatr. 2016 Sep 1;170(9):871-7. doi: 10.1001/jamapediatrics.2016.1196.

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