Published Online: November 4, 2013. doi:10.1001/jama.2013.280928.
Study concept and design: Courcoulas, Belle, Berk, Flum, King, Mitchell, Pomp, Pories, Yanovski, Wolfe.
Acquisition of data: Courcoulas, Flum, Mitchell, Patterson, Pender, Pomp, Pories, Wolfe.
Analysis and interpretation of data: Courcoulas, Christian, Belle, Berk, Flum, Garcia, Horlick, Kalarchian, King, Pories, Thirlby, Yanovski, Wolfe.
Drafting of the manuscript: Courcoulas, Christian, Berk, Flum, Pories.
Critical revision of the manuscript for important intellectual content: Courcoulas, Christian, Belle, Berk, Flum, Garcia, Horlick, Kalarchian, King, Mitchell, Patterson, Pender, Pomp, Pories, Thirlby, Yanovski, Wolfe.
Statistical analysis: Christian, Belle.
Obtained funding: Courcoulas, Belle, Berk, Flum, Mitchell, Pomp, Pories, Wolfe.
Administrative, technical, or material support: Courcoulas, Belle, Horlick, Kalarchian, Patterson, Pories, Wolfe.
Study supervision: Courcoulas, Belle, Berk, Flum, Pender, Pomp, Pories, Thirlby, Wolfe.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Courcoulas reported having received research grants from Allergan, Pfizer, Covidien, EndoGastric Solutions, and Nutrisystem and serving on the scientific advisory board of Ethicon J & J Healthcare System. Dr Flum reported having received research grants from Covidien and sanofi-aventis. Dr Kalarchian reported having received a research grant from Nutrisystem and support from the Obesity Society for the Use of Nutrisystem after Bariatric Surgery. Dr Mitchell reported having received a research grant from Shire Pharmaceuticals. Dr Patterson reported being a consultant for Ethicon Endosurgery and for the manufacturer of the Lap-band, Allergan Health, a company that may have a commercial interest in the results of this research. This potential conflict of interest has been reviewed and managed by Oregon Health and Science University. Dr Pender reported having received research grants from GlaxoSmithKline and Covidien. Dr Pories reported having received research grants from Ethicon and GlaxoSmithKline. Dr Wolfe reported being a consultant and advisor for Covidien, Ethicon, Crospon, Viudico, and Medtronics and having received a research grant from Enteromedics. No other disclosures were reported.
Funding/Support: LABS-2 was a cooperative agreement funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) with grants for the data coordinating center (U01 DK066557), Columbia University Medical Center (U01-DK66667) (in collaboration with Cornell University Medical Center Clinical and Translational Research Center [CTRC], grant UL1-RR024996), University of Washington (U01-DK66568) (in collaboration with CTRC, grant M01RR-00037), Neuropsychiatric Research Institute (U01-DK66471), East Carolina University (U01-DK66526), University of Pittsburgh Medical Center (U01-DK66585) (in collaboration with CTRC, grant UL1-RR024153), and Oregon Health and Science University (U01-DK66555).
Role of the Sponsor: The NIDDK scientists contributed to the design and conduct of the study, which included collection and management of data. The project scientist from the NIDDK served as a member of the steering committee, along with the principal investigator from each clinical site and the data coordinating center. The data coordinating center housed all data during the study and performed data analyses according to a prespecified plan developed by the data coordinating center biostatistician and approved by the steering committee and independent data and safety monitoring board. The decision to publish was made by the Longitudinal Assessment of Bariatric Surgery-2 steering committee, with no restrictions imposed by the sponsor. As a coauthor, an NIDDK scientist contributed to the interpretation of the data and preparation, review, and approval of the manuscript.