TY - JOUR
T1 - Comparison of surgical and medical therapy for type 2 diabetes in severely obese adolescents
AU - Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) Consortia
AU - Inge, Thomas H.
AU - Laffel, Lori M.
AU - Jenkins, Todd M.
AU - Marcus, Marsha D.
AU - Leibel, Natasha I.
AU - Brandt, Mary L.
AU - Haymond, Morey
AU - Urbina, Elaine M.
AU - Dolan, Lawrence M.
AU - Zeitler, Philip S.
AU - McKay, Siripoo
AU - Anderson, Barbara
AU - Bush, Cresendo
AU - Gunn, Sheila
AU - Holden, Heather
AU - Jones, Mary
AU - Jeha, George
AU - McGirk, Sue
AU - Thamotharan, Sneha
AU - Cuttler, Leona
AU - Abrams, Ericka
AU - Casey, Terri
AU - Dahms, Bill
AU - Ievers-Landis, Carolyn
AU - Kaminski, Beth
AU - Koontz, Michaela
AU - MacLeish, Sarah
AU - McGuigan, Paul
AU - Narasimhan, Sumana
AU - Geffner, Mitchell
AU - Barraza, Veronica
AU - Chang, Nancy
AU - Conrad, Barry
AU - Dreimane, Daina
AU - Estrada, Silvia
AU - Fisher, Lynda
AU - Fleury-Milfort, Evelyne
AU - Hernandez, Socorro
AU - Hollen, Barbara
AU - Kaufman, Francine
AU - Law, Emily
AU - Mansilla, Vanessa
AU - Miller, Debra
AU - Muñoz, Cynthia
AU - Ortiz, Rosa
AU - Ward, Andriette
AU - Wexler, Keren
AU - Xu, Y. K.
AU - Yasuda, Patrice
AU - Sherman, Vadim
N1 - Funding Information:
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.
Publisher Copyright:
© 2018 American Medical Association. All rights reserved.
PY - 2018/5
Y1 - 2018/5
N2 - 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 receivemetformin 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.
AB - 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 receivemetformin 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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U2 - 10.1001/jamapediatrics.2017.5763
DO - 10.1001/jamapediatrics.2017.5763
M3 - Article
C2 - 29532078
AN - SCOPUS:85046740894
VL - 172
SP - 452
EP - 460
JO - JAMA Pediatrics
JF - JAMA Pediatrics
SN - 2168-6203
IS - 5
ER -