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      Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass : The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study

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          Key Points

          Question

          How do type 2 diabetes (T2DM) outcomes compare across the 2 most common bariatric procedures?

          Findings

          In this cohort study of 9710 adults with T2DM who underwent bariatric surgery, most patients who had Roux-en-Y gastric bypass or sleeve gastrectomy experienced T2DM remission at some point over 5 years of follow-up. Patients who had Roux-en-Y gastric bypass showed slightly higher T2DM remission rates, better glycemic control, and fewer T2DM relapse events than patients who had sleeve gastrectomy.

          Meaning

          Understanding diabetes outcomes of different bariatric procedures will help surgeons and patients with diabetes make informed health care choices.

          Abstract

          This cohort study evaluates associations of sleeve gastrectomy and Roux-en-Y gastric bypass bariatric surgery with type 2 diabetes outcomes in adult patients.

          Abstract

          Importance

          Bariatric surgery can lead to substantial improvements in type 2 diabetes (T2DM), but outcomes vary across procedures and populations. It is unclear which bariatric procedure has the most benefits for patients with T2DM.

          Objective

          To evaluate associations of bariatric surgery with T2DM outcomes.

          Design, Setting, and Participants

          This cohort study was conducted in 34 US health system sites in the National Patient-Centered Clinical Research Network Bariatric Study. Adult patients with T2DM who had bariatric surgery between January 1, 2005, and September 30, 2015, were included. Data analysis was conducted from April 2017 to August 2019.

          Interventions

          Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).

          Main Outcome and Measures

          Type 2 diabetes remission, T2DM relapse, percentage of total weight lost, and change in glycosylated hemoglobin (hemoglobin A 1c).

          Results

          A total of 9710 patients were included (median [interquartile range] follow-up time, 2.7 [2.9] years; 7051 female patients [72.6%]; mean [SD] age, 49.8 [10.5] years; mean [SD] BMI, 49.0 [8.4]; 6040 white patients [72.2%]). Weight loss was significantly greater with RYGB than SG at 1 year (mean difference, 6.3 [95% CI, 5.8-6.7] percentage points) and 5 years (mean difference, 8.1 [95% CI, 6.6-9.6] percentage points). The T2DM remission rate was approximately 10% higher in patients who had RYGB (hazard ratio, 1.10 [95% CI, 1.04-1.16]) than those who had SG. Estimated adjusted cumulative T2DM remission rates for patients who had RYGB and SG were 59.2% (95% CI, 57.7%-60.7%) and 55.9% (95% CI, 53.9%-57.9%), respectively, at 1 year and 86.1% (95% CI, 84.7%-87.3%) and 83.5% (95% CI, 81.6%-85.1%) at 5 years postsurgery. Among 6141 patients who experienced T2DM remission, the subsequent T2DM relapse rate was lower for those who had RYGB than those who had SG (hazard ratio, 0.75 [95% CI, 0.67-0.84]). Estimated relapse rates for those who had RYGB and SG were 8.4% (95% CI, 7.4%-9.3%) and 11.0% (95% CI, 9.6%-12.4%) at 1 year and 33.1% (95% CI, 29.6%-36.5%) and 41.6% (95% CI, 36.8%-46.1%) at 5 years after surgery. At 5 years, compared with baseline, hemoglobin A 1c was reduced 0.45 (95% CI, 0.27-0.63) percentage points more for patients who had RYGB vs patients who had SG.

          Conclusions and Relevance

          In this large multicenter study, patients who had RYGB had greater weight loss, a slightly higher T2DM remission rate, less T2DM relapse, and better long-term glycemic control compared with those who had SG. These findings can help inform patient-centered surgical decision-making.

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          Most cited references46

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          Regularization Paths for Generalized Linear Models via Coordinate Descent

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            2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2019

            (2018)
            The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
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              Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5-Year Outcomes

              Background Long-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited. Methods We assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications. Results Of the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention-to-treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (-23%, -19%, and -5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (-40%, -29%, and -8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (-35%, -34%, and -13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation. Conclusions Five-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo-Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809 .).
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                Author and article information

                Journal
                JAMA Surg
                JAMA Surg
                JAMA Surgery
                American Medical Association
                2168-6254
                2168-6262
                May 2020
                4 March 2020
                4 March 2020
                : 155
                : 5
                : e200087
                Affiliations
                [1 ]Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
                [2 ]Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania
                [3 ]Kaiser Permanente Washington Health Research Institute, Seattle
                [4 ]Louisiana Public Health Institute, New Orleans
                [5 ]Center for Health Technology, University of California, Davis, Davis
                [6 ]PaTH Clinical Data Research Network, Pennsylvania State University, Hershey
                [7 ]Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena
                [8 ]Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania
                [9 ]Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts
                [10 ]Duke Clinical & Translational Science Institute, Durham, North Carolina
                [11 ]Mid-South Clinical Data Research Network, Meharry-Vanderbilt Alliance Community Partner, Nashville, Tennessee
                [12 ]Now with Community Partners Network Inc, Nashville, Tennessee
                Author notes
                Article Information
                Group Information: PCORnet Bariatric Study Collaborative members appear at the end of the article.
                Accepted for Publication: January 15, 2020.
                Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 McTigue KM et al. JAMA Surgery.
                Corresponding Author: Kathleen McTigue, MD, Department of Medicine, University of Pittsburgh, 230 McKee Pl, Ste 600, Pittsburgh, PA 15213 ( kmm34@ 123456pitt.edu ).
                Published Online: March 4, 2020. doi:10.1001/jamasurg.2020.0087
                Correction: This article was corrected on March 25, 2020, to fix an error in the name of a healthcare organization. The name was rendered as “the National Patient-Centered Clinical Research Network (PCORnet),” but it should have been “PCORnet, the National Patient-Centered Clinical Research Network.” This occurred once in the Introduction section and once in the Funding/Support section of the Article Information section. Both have been fixed online.
                Author Contributions: Drs McTigue and Arterburn had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
                Concept and design: McTigue, Wellman, Coley, Toh, Janning, Williams, Arterburn.
                Acquisition, analysis, or interpretation of data: McTigue, Wellman, Nauman, Anau, Coley, Tice, Coleman, Courcoulas, Pardee, Toh, Cook, Sturtevant, Horgan, Arterburn.
                Drafting of the manuscript: McTigue, Wellman, Anau, Coley, Coleman, Janning, Arterburn.
                Critical revision of the manuscript for important intellectual content: McTigue, Wellman, Nauman, Anau, Coley, Tice, Courcoulas, Pardee, Toh, Williams, Cook, Sturtevant, Horgan, Arterburn.
                Statistical analysis: Wellman, Coley, Toh, Cook.
                Obtained funding: McTigue, Anau, Arterburn.
                Administrative, technical, or material support: McTigue, Nauman, Anau, Coleman, Courcoulas, Pardee, Sturtevant, Horgan.
                Supervision: Coleman, Arterburn.
                Other—patient perspective: Janning.
                Conflict of Interest Disclosures: Dr Courcoulas reports grants from Covidien/Ethicon Johnson & Johnson, during the conduct of the study. Dr Tavakkoli reports personal fees from Medtronic and AMAG pharmaceuticals. Dr Jones reports personal fees from Allurion. Mr Nadglowski reports other support from the Obesity Action Coalition outside the submitted work.
                Funding/Support: The PCORnet Study reported in this article was conducted using PCORnet, the National Patient-Centered Clinical Research Network, an initiative funded by the Patient-Centered Outcomes Research Institute (grant OBS-1505-30683).
                Role of the Funder/Sponsor : The funder did not have a role in the study design; in the collection, management, analysis, and interpretation of data; in the preparation, review, or approval of the manuscript; and in the decision to submit the manuscript for publication.
                PCORnet Bariatric Study Collaborative: Corrigan L. McBride, MD, and James McClay, MD, University of Nebraska Medical Center, Omaha; Jeanne M. Clark, MD, Johns Hopkins University and Health Plan, Baltimore, Maryland; Thomas H. Inge, MD, Children’s Hospital Colorado and University of Colorado, Denver; Michelle R. Lent, PhD, Geisinger Health System, Danville, Pennsylvania; David G. Schlundt, PhD, Vanderbilt University, Nashville, Tennessee; Meredith Duke, MD, University of North Carolina–Chapel Hill; Steven R. Smith, MD, Florida Hospital–Translational Research Institute, Orlando; Andrew O. Odegaard, PhD, University of California, Irvine; Nirav K. Desai, MD, Boston Children’s Hospital, Boston, Massachusetts; Ali Tavakkoli, MD, and Elizabeth Cirelli, MS, Brigham and Women’s Hospital, Boston, Massachusetts; Stavra A. Xanthakos, MD, Cincinnati Children's Medical Center, Cincinnati, Ohio; Laura J. Rasmussen-Torvik, PhD, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Marc P. Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio; Matthew F. Daley, MD, Institute for Health Research, Kaiser Permanente Colorado, Aurora; Gabrielle Purcell, MPH. University of California; San Francisco; Sameer Murali, MD, Southern California Permanente Medical Group, Fontana; Ana Emiliano, MD, and Rhonda G. Kost, MD, The Rockefeller University, New York, New York; Caroline M. Apovian, MD, and Donald Hess, MD, Boston Medical Center, Boston, Massachusetts; Cynthia A. Blalock, APRN, Vanderbilt University Medical Center, Nashville, Tennessee; Elisha Malanga, BS, COPD Foundation, Miami, Florida; Jay R. Desai, MD, HealthPartners Institute, Bloomington, Minnesota; Joe Nadglowski, BS, Obesity Action Coalition, Tampa, Florida; John H. Holmes, PhD, University of Pennsylvania Perelman School of Medicine, Philadelphia; Joseph Vitello, MD, Jesse Brown VA Medical Center, Chicago, Illinois; Michael A. Horberg, MD, Kaiser Permanente Mid-Atlantic Permanente Medical Group, Rockville, Maryland; Robert T. Greenlee, PhD, Marshfield Clinic Research Institute, Marshfield, Wisconsin; Stephanie L. Fitzpatrick, PhD, Kaiser Permanente Center for Health Research, Portland, Oregon; Roni Zeiger, MD, Smart Patients, Inc, Mountain View, California; Molly B. Conroy, MD, University of Utah, Salt Lake City; Douglas S. Bell, MD, David Geffen School of Medicine at UCLA, Los Angeles, California; Jamy Ard, MD, Wake Forest School of Medicine, Salem, North Carolina; Jing Bian, PhD, University of Florida, Gainesville; Bipan Chan, MD, Loyola University Medical Center, Maywood, Illinois; Michael A. Edwards, MD, Temple University, Philadelphia, Pennsylvania; Christina Wee, MD, and Daniel B. Jones, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Jennifer L. Kraschnewski, MD, Penn State University, College of Medicine, Hershey, Pennsylvania; Kirk Reichard, MD, Nemours AI DuPont Hospital for Children, Wilmington, Delaware; Howard S. Gordon, MD, and David O. Meltzer MD, University of Illinois, Chicago; Erin D. Roe, MD, Baylor Scott & White, Dallas, Texas; William Richardson, MD, Ochsner Clinic, New Orleans, Louisiana; Sameer Malhotra, MD, Weill Cornell Medicine, New York, New York; Lindsay G. Cowell, PhD, University of Texas Southwestern Medical Center, Dallas; Lydia A. Bazzano, MD, PhD, Tulane University, New Orleans, Louisiana; Jefferey S. Brown, Sengwee Toh, ScD, Jessica L. Sturtevant, MS, and Casie Horgan, MPH, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Anita Courcoulas, MD, Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, and Kathleen McTigue, MD, Departments of Medicine and Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania; R. Yates Coley, PhD, David Arterburn, MD, Robert Wellman, MS, Jane Anau, BS, Roy E. Pardee, JD, and Andrea J. Cook, PhD, Kaiser Permanente Washington Health Research Institute, Seattle; Karen J. Coleman, PhD, Kaiser Permanente Southern California, Department of Research and Evaluation, Pasadena; Cheri D. Janning, MS, Duke Clinical & Translational Science Institute, Durham, North Carolina; Neely Williams, MDiv, Mid-South Clinical Data Research Network and Meharry–Vanderbilt Alliance Community Partner, Nashville, Tennessee.
                Disclaimer: The views expressed in this article are solely those of the authors and do not reflect the views of PCORnet or PCORI. Dr McTigue attests that all listed authors meet authorship criteria and nobody meeting authorship criteria has been omitted.
                Additional Contributions: The study team also wishes to acknowledge the clinicians, analysts, and staff at the 34 health systems which contributed to the study: Stephen R. Perry, Kin Lam, David Hawkes, Thomas Dundon, and Kelli Kinsman, Kaiser Permanente Washington Health Research Institute, Shelly Sital, The Chicago Community Trust, Elizabeth Tarlov, University of Illinois at Chicago, Jasmin Phua, Medical Research Analytics and Informatics Alliance, Mia Gallagher, Lindsey Petro, Beth Syat, Harvard Pilgrim Health Care Institute and Harvard Medical School, Prakash Nadkarni, and Elizabeth Chrischilles, University of Iowa, Steffani Roush, and Laurel Verhagen, Marshfield Clinic Research Institute, Umberto Tachincardi, and Lawrence P. Hanrahan, University of Wisconsin, Phillip Reeder, Shiby Antony, Rania AlShahrouri, University of Texas–Southwestern Medical Center, Bret Gardner, James Campbell, Russell Buzalko, and Jay Pedersen, University of Nebraska Medical Center, Dan Connolly, and Russel Waitman, University of Kansas Medical Center, Russel Rothman, David Crenshaw, and Katie Worley, Vanderbilt University Medical Center, Emily Pfaff, Robert Bradford, Kellie Walters, Tim Carey, Timothy Farrell, and D. Wayne Overby, University of North Carolina, Maija Neville-Williams, The Rockefeller University, Elizabeth Shenkman, William Hogan, Kathryn McAuliffe, and Gigi Lipori, University of Florida, Rebecca Zuvich Essner, Florida Hospital, Howard Su, Michael George, Michael J. Becich, Barbara Postol, Giselle G. Hamad, Ramesh C. Ramanathan, Bestoun H. Ahmed, William F. Gourash, Bill Shirey, Chuck Borromeo, John Milnes, Nickie Cappella, and Desheng Li, University of Pittsburgh, Anthony T. Petrick, H. Lester Kirchner, Geisinger Health System, Daniel E. Ford, Michael A. Schweitzer, Karl Burke, Harold Lehmann, Megan E. Gauvey-Kern, and Diana Gumas. Johns Hopkins, Rachel Hess, Meghan Lynch, and Reid Holbrook, University of Utah, Jody McCullough, Matt Bolton, Wenke Hwang, Ann Rogers, Alison Bower, and Cynthia Chuang, Penn State, Cecilia Dobi, Mark Weiner, Anuradha Paranjape, Sharon J. Herring, and Patricia Bernard, Temple University, Janet Zahner, Parth Divekar, Keith Marsolo, and Lisa Boerger, Cincinnati Children’s Hospital, Kimberly J. Holmquist, Kaiser Permanente Southern California, Ray Pablo and Robynn Zender, University of California at Irvine, Lucila Ohno-Machado, Paulina Paul, and Michele Day, University of California at San Diego, Thomas Carton, Elizabeth Crull, and Iben McCormick-Ricket, Louisiana Public Health Institute, Ashley Vernon, Malcom Robinson, Scott Shikora, David Spector, Eric Sheu, Edward Mun, Matthew Hutter, Shawn Murphy, Jeffrey Klann, and Denise Gee, Partners Healthcare, Daniel Jones, Benjamin Schneider, Griffin Weber, and Robert Andrews, Beth Israel Deaconess Medical Center, Brian Carmine, Miguel Burch, and Galina Lozinski, Boston Medical Center, Ken Mandl, Jessica Lyons, and Margaret Vella, Harvard Medical School, and Joseph Skelton and Kun Wei, Wake Forest Integrated Health System. Some of these individuals were compensated for their contributions.
                Article
                soi200005
                10.1001/jamasurg.2020.0087
                7057171
                32129809
                238a9a1b-f45a-4d93-b6c9-ad4b9340fdf6
                Copyright 2020 McTigue KM et al. JAMA Surgery.

                This is an open access article distributed under the terms of the CC-BY License.

                History
                : 4 November 2019
                : 15 January 2020
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