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Comparison of Surgical and Medical Therapy for Type 2 Diabetes in Severely Obese Adolescents

Educational Objective
To compare glycemic control in cohorts of severely obese adolescents with type 2 diabetes undergoing medical or surgical interventions.
1 Credit CME
Key Points

Question  How does bariatric surgery compare with medical therapy to treat type 2 diabetes in adolescents with severe obesity?

Findings  In this study of 93 severely obese adolescents with type 2 diabetes, hemoglobin A1c concentration and mean body mass index decreased in 30 patients who underwent surgical treatment and increased in 63 patients who received medical treatment at 2-year follow-up. Significant improvements in blood pressure, dyslipidemia, and abnormal kidney function were also observed in the patients treated surgically but not in those treated medically.

Meaning  Surgical treatment of severely obese adolescents with type 2 diabetes was associated with better glycemic control, reduced cardiovascular risk markers, and improved kidney function; these findings support the need for a well-designed, prospective controlled study to define the role of surgery for adolescents with type 2 diabetes.

Abstract

Importance  Because of the substantial increase in the occurrence of type 2 diabetes in the pediatric population and the medical complications of this condition, therapies are urgently needed that will achieve better glycemic control than standard medical management.

Objective  To compare glycemic control in cohorts of severely obese adolescents with type 2 diabetes undergoing medical and surgical interventions.

Design, Setting, and Participants  A secondary analysis of data collected by the Teen–Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) consortia was performed. Teen-LABS enrolled 242 adolescents (≤19 years of age) from March 1, 2007, through December 31, 2011. TODAY randomized 699 participants (aged 10-17 years) from July 24, 2004, through February 25, 2009. Data analysis was performed from July 6, 2015, to June 24, 2017. Anthropometric, clinical, and laboratory data from adolescents with severe obesity and type 2 diabetes who underwent treatment with metabolic or bariatric surgery in the Teen-LABS study or medical therapy in the TODAY study were compared.

Interventions  Teen-LABS participants underwent a primary bariatric surgical procedure; TODAY participants were randomized to receive metformin therapy alone or in combination with rosiglitazone or an intensive lifestyle intervention; insulin therapy was given in cases of progression of disease.

Main Outcomes and Measures  Glycemic control, body mass index, prevalence of elevated blood pressure, dyslipidemia, abnormal kidney function, and clinical adverse events were measured.

Results  Data from 30 participants from Teen-LABS (mean [SD] age at baseline, 16.9 [1.3] years; 21 [70%] female; 18 [66%] white) and 63 from TODAY (mean [SD] age at baseline, 15.3 [1.3] years; 28 [44%] female; 45 [71%] white) were analyzed. During 2 years, mean hemoglobin A1c concentration decreased from 6.8% (95% CI, 6.4%-7.3%) to 5.5% (95% CI, 4.7% -6.3%) in Teen-LABS and increased from 6.4% (95% CI, 6.1%-6.7%) to 7.8% (95% CI, 7.2%-8.3%) in TODAY. Compared with baseline, the body mass index decreased by 29% (95% CI, 24%-34%) in Teen-LABS and increased by 3.7% (95% CI, 0.8%-6.7%) in TODAY. Twenty-three percent of Teen-LABS participants required a subsequent operation during the 2-year follow-up.

Conclusions and Relevance  Compared with medical therapy, surgical treatment of severely obese adolescents with type 2 diabetes was associated with better glycemic control, reduced weight, and improvement of other comorbidities. These data support the need for a well-designed, prospective controlled study to define the role of surgery for adolescents with type 2 diabetes, including health and surgical outcomes.

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Article Information

Accepted for Publication: December 21, 2017.

Corresponding Author: Thomas H. Inge, MD, PhD, Department of Pediatric Surgery, Children's Hospital Colorado, 13123 E 16th Ave, Box 323, Aurora, CO 80045-7106 (thomas.inge@childrenscolorado.org).

Published Online: March 12, 2018. doi:10.1001/jamapediatrics.2017.5763

Author Contributions: Dr Jenkins had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Inge, Jenkins, Brandt, Haymond, Dolan, Zeitler.

Acquisition, analysis, or interpretation of data: Laffel, Jenkins, Marcus, Leibel, Haymond, Urbina, Dolan, Zeitler.

Drafting of the manuscript: Laffel, Jenkins, Marcus, Urbina, Zeitler.

Critical revision of the manuscript for important intellectual content: Inge, Laffel, Jenkins, Leibel, Brandt, Haymond, Urbina, Dolan, Zeitler.

Statistical analysis: Jenkins, Zeitler.

Obtained funding: Inge, Zeitler.

Administrative, technical, or material support: Laffel, Marcus, Urbina.

Supervision: Laffel, Urbina, Dolan, Zeitler.

Conflict of Interest Disclosures: Dr Inge reported serving as a consultant for Standard Bariatrics, unrelated to this project. Dr Laffel reported receiving support from AstraZeneca, Boehringer Ingelheim Pharmaceuticals Inc, Dexcom Inc, Eli Lilly and Company, Insulet, Johnson & Johnson, MannKind Corporation, Menarini, Diagnostics, Novo Nordisk Inc, Roche Diagnostics, and Sanofi US, all unrelated to this project. Dr Marcus reported serving on the scientific advisory board of Weight Watchers International Inc. Dr Zeitler reported participating in research design consulting for Daichii-Sankyo, Merck, Janssen, Takeda, and Eli Lilly and Company. No other disclosures were reported.

Funding/Support: This work was completed with funding from grants U01-DK61212, U01-DK61230, U01-DK61239, U01-DK61242, U01-DK61254, U01DK072493, UM1DK072493, and UM1DK095710 from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institutes of Health Office of the Director (University of Cincinnati); grants M01-RR00036 (Washington University School of Medicine), M01-RR00043-45 (Children’s Hospital Los Angeles), M01-RR00069 (University of Colorado Denver), M01-RR00084 (Children’s Hospital of Pittsburgh), M01-RR01066 (Massachusetts General Hospital), M01-RR00125 (Yale University), and M01-RR14467 (University of Oklahoma Health Sciences Center) from the National Center for Research Resources General Clinical Research Centers Program; and grants UL1-RR024134 (Children’s Hospital of Philadelphia), UL1-RR024139 (Yale University), UL1-RR024153 (Children’s Hospital of Pittsburgh), UL1-RR024989 (Case Western Reserve University), UL1-RR024992 (Washington University in St Louis), UL1-RR025758 (Massachusetts General Hospital), and UL1-RR025780 (University of Colorado Denver) from the National Centre for Advancing Translational Science Awards. The Teen-LABS study was also supported by grants UL1 TR000077-04 (Cincinnati Children’s Hospital Medical Center), UL1RR025755 (Nationwide Children’s Hospital), M01-RR00188 (Texas Children’s Hospital/Baylor College of Medicine), UL1 RR024153 and UL1TR000005 (University of Pittsburgh), and UL1 TR000165 (University of Alabama, Birmingham) from the National Center for Research Resources Clinical and Translational Science Awards.

Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Members: The following individuals and institutions constitute the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) Study Group (asterisk indicates principal investigator or director): Clinical Centers: Baylor College of Medicine: Siripoo McKay, MD,* Morey Haymond, MD,* Barbara Anderson, PhD, Cresendo Bush, Sheila Gunn, MD, Heather Holden, Mary Jones, George Jeha, MD, Sue McGirk, Sneha Thamotharan; Case Western Reserve University: Leona Cuttler, MD,* Ericka Abrams, Terri Casey, Bill Dahms, MD* (deceased), Carolyn Ievers-Landis, PhD, Beth Kaminski, Michaela Koontz, MD, Sarah MacLeish, Paul McGuigan, Sumana Narasimhan, MD*; Children’s Hospital Los Angeles: Mitchell Geffner, MD,* Veronica Barraza, Nancy Chang, Barry Conrad, Daina Dreimane, MD, Silvia Estrada, Lynda Fisher, MD, Evelyne Fleury-Milfort, Socorro Hernandez, Barbara Hollen, Francine Kaufman, MD, Emily Law, Vanessa Mansilla, Debra Miller, Cynthia Muñoz, Rosa Ortiz, Andriette Ward, MD, Keren Wexler, Y. K. Xu, Patrice Yasuda, PhD; Children's Hospital of Philadelphia: Lorraine Levitt Katz, MD,* Robert Berkowitz, MD, Sakeenah Boyd, Bonnie Johnson, Joan Kaplan, PhD, Catherine Keating, Chad Lassiter, Terri Lipman, PhD, Gerre McGinley, Heather McKnight-Menci, Beth Schwartzman, Steven Willi, MD; Children's Hospital of Pittsburgh: Silva Arslanian, MD,* Fida Bacha, MD, Sally Foster, Bryan Galvin, Tamara Hannon, Andrea Kriska, PhD, Ingrid Libman, MD, Marsha Marcus, PhD, Kristin Porter, Thomas Songer, PhD, Elizabeth Venditti, PhD; Columbia University Medical Center: Robin Goland, MD,* Dympna Gallagher, Patricia Kringas, Natasha Leibel, MD, Debbie Ng, Martin Ovalles, Daniel Seidman; Joslin Diabetes Center: Lori Laffel, MD,* Ann Goebel-Fabbri, Melanie Hall, Laurie Higgins, Joyce Keady, Maureen Malloy, Kerry Milaszewski, Lisa Rasbach; Massachusetts General Hospital: David Nathan, MDm* Amanda Angelescu, MD, Laurie Bissett, Carol Ciccarelli, Linda Delahanty, Valerie Goldman, Olga Hardy, MD, Mary Larkin, Lynne Levitsky, MD,* Rebecca McEachern, MD, Dennis Norman, PhD, Benjamin Nwosu, MD, Soja Park-Bennett, MD, Denise Richards, Nicole Sherry, MD, Barbara Steiner; Saint Louis University: Sherida Tollefsen, MD,* Silvia Carnes, David Dempsher, MD, David Flomo, Theresa Whelan, Bonita Wolff; State University of New York Upstate Medical University: Ruth Weinstock, MD, PhD,* Deborah Bowerman, Suzan Bristol, Jane Bulger, Jennifer Hartsig, Roberto Izquierdo, MD, Joanne Kearns, Ron Saletsky, PhD, Paula Trief, PhD; University of Colorado, Denver: Philip Zeitler, MD, PhD* (steering committee chair), Natalie Abramson, PhD, Amanda Bradhurst, Nicole Celona-Jacobs, Janine Higgins, PhD, Megan Kelsey, MD, Georgeanna Klingensmith, MD, Kristen Nadeau, MD, Teresa Witten; University of Oklahoma Health Sciences Center: Kenneth Copeland, MD* (steering committee vice-chair), Evynn Boss, Ryan Brown, MD, Jennifer Chadwick, Laura Chalmers, MD, Steven Chernausek, MD, Ashley Hebensperger, Chris Macha, Rebecca Newgent, Allison Nordyke, Donna Olson, Tawney Poulsen, Lauren Pratt, Jeff Preske, Jill Schanuel, Steve Sternlof, PhD; University of Texas Health Science Center at San Antonio: Jane Lynch, MD,* Nancy Amodei, Rose Ann Barajas, Catherine Cody, Dan Hale, MD, J. Hernandez, Cori Ibarra, Elisa Morales, Semilla Rivera, Guadalupe Rupert, Aimee Wauters; Washington University in St Louis: Neil White, MD,* Ana Arbeláez, MD, David Flomo, Jackie Jones, Tracy Jones, Michelle Sadler, Marilyn Tanner, Alexis Timpson, Robinson Welch; Yale University: Sonia Caprio, MD,* Margaret Grey, PhD, Cindy Guandalini, Sylvia Lavietes, PhD, Paulina Rose, Amy Syme, William Tamborlane, MD; Coordinating Center: George Washington University Biostatistics Center: Kathryn Hirst, PhD,* Sharon Edelstein, Preethy Feit, Nisha Grover, Christen Long, Laura Pyle; Project Office: National Institute of Diabetes and Digestive and Kidney Diseases: Barbara Linder,* MD, PhD; Central Units; Central Blood Laboratory (Northwest Lipid Research Laboratories, University of Washington): Santica Marcovina, PhD,* Jessica Harting; DEXA Reading Center (University of California at San Francisco): John Shepherd, PhD,* Bo Fan, Lorena Marquez, Mary Sherman, Jeff Wang; Diet Assessment Center (University of South Carolina): Michele Nichols,* Beth Mayer-Davis, PhD, Yuan Liu; Echocardiogram Reading Center (Johns Hopkins University): Joao Lima, MD,* Sam Gidding, MD, JoAnn Puccella, Erin Ricketts; Fundus Photography Reading Center (University of Wisconsin): Ronald Danis, PhD,* Amitha Domalpally, Anne Goulding, Sherri Neill, Pam Vargo; Lifestyle Program Core (Washington University): Denise Wilfley, PhD,* Deb Aldrich-Rasche, K. Franklin, Cherie Massmann, Dennis O’Brien, Jeremy Patterson, Tiffany Tibbs, PhD, Dorothy Van Buren, PhD; Other: Hospital for Sick Children, Toronto: Mark Palmert, MD, Medstar Research Institute, Washington, DC: Robert Ratner, MD, Texas Tech University Health Sciences Center: Daina Dremaine, MD, University of Florida: Janet Silverstein, MD; University of Cincinnati: Mark Simmons, PhDc; Texas Children’s Hospital, Baylor College of Medicine: Vadim Sherman, MD, Margaret Callie Lee, MPH, David Allen, BS, Natoya Caston, BSN, Keri Turybury, MS, RD, LD, Gia Washington, PhD, Karin Price, PhD; Children’s Hospital of Alabama, University of Alabama: Ronald Clements, MD, Richard Stahl, MD, Molly Bray, PhD, Beverly Haynes, BSN, Heather Austin, PhD, Constance Cushing, DPT; University of Pittsburgh Medical Center: Ramesh Ramanathan, MD, Carol A. McCloskey, MD, George M. Eid, MD, Jessie Eagleton, MPH, William Gourash, MSN, CRNP, Lindsay Lee, MS, RD, Sheila Pierson, BS, Catherine Gibbs, MS, Dana Farrell, BS, Christopher Coburn, PhD, Dana Rofey, PhD, Rebecca Search, MPH, Mark Shaw, MS, Eleanor Shirley, MA, Kevin Topolski, MEd; Nationwide Children’s Hospital: Steven Teich, MD, Allen Browne, MD, Karen Carter, CCRC, Melinda Helton, RN, Bonny Bowen, RN, Cynthia Yensel, RN, MS, Patsy Guittar, MSN, Deanna Lear, RN, MS, Robert David Murray, MD, Andrea Hedge, Kevin Smith, PhD, Amy Baughcum, PhD, Grace Wentzel, CCRP, Paula Davies, CCRC; National Institute of Diabetes and Digestive and Kidney Diseases: Mary Evans, PhD; Other Collaborators: Santica M. Marcovina, PhD, ScD, Northwest Lipid Research Laboratory, University of Washington, David E. Kleiner, MD, PhD, National Cancer Institute, National Institutes of Health, Stephen Daniels, MD, PhD, University of Colorado.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Additional Contributions: Jane Khoury, PhD, and Changchun Xie, PhD, provided statistical expertise. The following individuals contributed to the successful planning and/or execution of the study: Cincinnati Children’s Hospital Medical Center: Michael Helmrath, MD, MS, Stavra Xanthakos, MD, MS; University of Cincinnati: Chanchung Xie, PhD; Texas Children’s Hospital, Baylor College of Medicine: Mary Brandt, MD; Children’s Hospital of Alabama, University of Alabama: Mike Chen, MD; University of Pittsburgh Medical Center: Anita Courcoulas, MD; Nationwide Children’s Hospital: Marc Michalsky, MD; National Institute of Diabetes and Digestive and Kidney Diseases: Mary Evans, PhD. Other Collaborators: Carroll M. Harmon, MD, PhD, Women and Children’s Hospital of Buffalo, Santica M. Marcovina, PhD, ScD, Director of Northwest Lipid Research Laboratory, University of Washington. We also thank the talented clinical staff at each site for their dedication to the patient population represented in this study and appreciate the important work done by the adjudication committee. The TODAY Study Group thanks the following companies for donations in support of the study’s efforts: Becton, Dickinson and Company, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, LifeScan Inc, Pfizer, and Sanofi Aventis. The TODAY Study Group acknowledges the participation and guidance of the American Indian partners associated with the clinical center located at the University of Oklahoma Health Sciences Center, including members of the Absentee Shawnee Tribe, Cherokee Nation, Chickasaw Nation, Choctaw Nation of Oklahoma, and Oklahoma City Area Indian Health Service (the opinions expressed in this article are those of the authors and do not necessarily reflect the views of the respective Tribal and Indian Health Service Institution Review Boards or their members). Materials developed and used for the TODAY standard diabetes education program and the intensive lifestyle intervention program are available to the public at https://today.bsc.gwu.edu/. The Teen-LABS Consortium thanks the central study coordinator, Rosie Miller, RN, CCRC, for her extraordinary dedication and resourcefulness in conduct of the study. These individuals were not personally compensated.

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