Author Contributions: Dr Connett and Ms Thomas 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.
Study concept and design: Ikramuddin, Korner, Connett, Inabnet, Billington, Thomas, Leslie, Jeffery, Ahmed, Bessler, Bantle.
Acquisition of data: Korner, Lee, Billington, Thomas, Chong, Ahmed, Vella, Chuang, Sarr, Swain, Laqua, Jensen, Bantle.
Analysis and interpretation of data: Korner, Connett, Inabnet, Billington, Thomas, Leslie, Ahmed, Vella, Sarr, Jensen, Bantle.
Drafting of the manuscript: Ikramuddin, Korner, Connett, Inabnet, Billington, Thomas, Leslie, Jeffery, Sarr, Jensen, Bantle.
Critical revision of the manuscript for important intellectual content: Korner, Lee, Connett, Inabnet, Billington, Thomas, Leslie, Chong, Ahmed, Vella, Chuang, Bessler, Sarr, Swain, Laqua, Jensen, Bantle.
Statistical analysis: Connett, Thomas.
Obtained funding: Ikramuddin.
Administrative, technical, or material support: Korner, Lee, Connett, Billington, Thomas, Leslie, Chong, Ahmed, Vella, Chuang, Sarr, Swain, Laqua, Jensen, Bantle.
Study supervision: Ikramuddin, Korner, Connett, Inabnet, Billington, Thomas, Vella, Chuang, Bessler, Sarr, Jensen.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ikramuddin reported that he serves on an advisory board member for Novo Nordisk, USGI and Medica, consults for Metamodix Inc and receives grant support from Covidien, EnteroMedics and ReShape Medical. Dr Korner reports receiving institutional and personal support from Covidien, serving on a Scientific Advisory Board for NutriSystem, consulting for Federal Table Commission, and receiving personal support for expert testimony. Dr Connett reports receiving institutional and personal grant support from Covidien, NIH grant support, and travel expenses and personal support for the FDA Advisory Panel on Pulmonary Drugs. Dr Billington reports receiving grant support from Covidien and personal support for consultancy from EnteroMedics Inc. Ms Thomas reports receiving salary support from Covidien for the Diabetes Surgery Study, as well as supplemental salary support from Minnesota Obesity Center. Dr Ahmed reports receiving institutional grant support from Covidien. Dr Vella reports receiving consulting support from sanofi-aventis, Roche, and Novartis; institutional consulting support from Merck, and institutional grant support from Covidien, Daiichi-Sankyo, Merck, and GI Dynamics. Dr Bessler reports receiving institutional grant support from Covidien, personal consulting support from Geshon Lehmar, and personal support for malpractice review. Dr Swain reports receiving grant support from EnteroMedics Inc and ReShape Medical. Ms Laqua reports receiving institutional NIH grant support from Covidien. Dr Jensen reports serving on an advisory board for Vivus and receiving institutional grant support from Aspire Bariatrics. Dr Bantle reports receiving institutional support for the Look AHEAD study. No other authors reported disclosures.
Funding/Support: The Diabetes Surgery Study was supported by Covidien, Mansfield, Massachusetts. Covidien provided funds for these 5 clinical locations: University of Minnesota, Minneapolis; Mayo Clinic, Rochester, Minnesota; Columbia University, New York, New York; National Taiwan University Hospital, Taipei, Taiwan; Min-Sheng General Hospital, Taoyuan, Taiwan. This publication was supported in part by grant UL1 TR000040 and grant UL1 RR024156 to Columbia University both from the National Center for Advancing Translational Sciences, National Institutes of Health, formerly the National Center for Research Resources.
Role of the Sponsors: The sponsoring agency had no role in the collection, management, analysis, and interpretation of the study data; and had no part in the preparation of the manuscript. The sponsor was allowed to review the manuscript prior to submission but had no role in the decision to submit the manuscript for publication.
Online-Only Material: The Author Video Interview is available .
Additional Contributions:Study Coordinators: Joyce Schone, RD, and Nyra Wimmergren, RN, University of Minnesota, Minneapolis; Heather A. Bainbridge, RD, CDN, from Columbia University Medical Center, New York, New York; Amy E. Reynolds, RN, Mayo Clinic, Rochester, Minnesota; Shu-Chun Chen, Linda Huang, and Meng-Jie Chen, National Taiwan University. Data Safety Monitoring Board members: David Nelson, PhD, Minnesota VA Health Care System, Minneapolis; Victor J. Stevens, PhD, the Center for Health Research, Portland, Oregon; J. Michael Gonzalez-Campoy, MD, PhD, FACE, Medical Director and CEO of the Minnesota Center for Obesity, Metabolic and Endocrinology Professional Association, Eagan, Minnesota; and Raymond Drew, MD, Abbott Northwestern Hospital, Minneapolis, Minnesota. The investigators recognize the contributions of the following individuals at the University of Minnesota Data Coordinating Center: Merrie J. Harrison, Alain DuChene, Terri Schultz, and Greg Thompson. Also at the University of Minnesota, we recognize the contributions of Stanley E. Williams, PhD, and acknowledge the tremendous assistance of Bridget M. Slusarek, RN. Michelle Lee, MD, is currently Associate Medical Director of Discovery Medicine and Clinical Pharmacology in CV/Metabolics at Bristol-Myers Squibb, Princeton, New Jersey, but was formerly the Assistant Professor of Clinical Medicine at Columbia University Medical Center for patient care. We extend our appreciation to Farah S. Khan, MD, Munir Abid, MD, and Gregory T. Mucha, MD, for patient referrals to our study. None of those named herein received compensation for those referrals.