IMPORTANCE The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown. OBJECTIVE To compare durability of Roux-en-Y gastric bypass added to intensive lifestyle and medical management in achieving diabetes control targets. DESIGN, SETTING, AND PARTICIPANTS Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120participantswhohad a hemoglobinA1c (HbA1c) level of 8.0%or higher and a body mass index between 30.0and 39.9 (enrolled between April 2008and December 2011)were followed up for 5 years, ending inNovember 2016. INTERVENTIONS Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without (60 participants each) Roux-en-Y gastric bypass surgery followed by observation to year 5. MAIN OUTCOMES AND MEASURES The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100mg/dL, and systolic blood pressure less than 130mmHg at 5 years. RESULTS Of 120 participants whowere initially randomized (mean age, 49 years [SD, 8 years], 72women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristicswere similar between groups: Mean (SD) body mass index 34.4 (3.2) for the lifestyle-medical management group and 34.9 (3.0) for the gastric bypass group and had hemoglobin A1c levels of 9.6%(1.2) and 9.6%(1.0), respectively. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95%CI, 4%-34%; P = .01). In the fifth year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical management group achieved an HbA1c level of less than 7.0%(difference, 41%; 95%CI, 19%-63%; P = .002). Gastric bypass had more serious adverse events than did the lifestyle-medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks. Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency. CONCLUSIONS AND RELEVANCE In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.
|Original language||English (US)|
|Number of pages||13|
|Journal||JAMA - Journal of the American Medical Association|
|State||Published - Jan 16 2018|
Bibliographical noteFunding Information:
Ikramuddin, Connett, Bantle, Inabnet, Jeffery, Chong, Chuang, Jensen, Vella, Ahmed, Billington. Supervision: Ikramuddin, Korner, Lee, Chuang, Vella, Billington. Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ikramuddin serves as an advisory board member for Novo Nordisk, USGI, and Medica, consults for Metamodix, and receives grant support from Medtronic, ReShape Medical, and institutional support from Enteromedics. Dr Korner reported that she has received institutional grant support from Medtronic and the National Institutes of Health (NIH), serves on the Scientific Advisory Board of Digma Medical, and had served on the speaker’s bureau for Takeda. Ms Thomas reports that she received institutional grant support from Medtronic and the NIH. Dr Connett reported that he has received institutional grant support from Medtronic and the NIH, travel expenses and personal support from the US Food and Drug Administration advisory panel on pulmonary drugs, salary support from Medtronic for the Diabetes Surgery Study, and supplemental salary support from the Minnesota Obesity Center and that he is employed by Optum. Dr Leslie reported receiving grant support from Medtronic. Dr Jensen reported receiving grant support from Covidian and personal fees from Novo Nordisk. Dr Jensen reported receiving institutional grant support from Covidien and consulting support from Novo Nordisk, Eisai, Genentech, and Takeda. Dr Vella reported receiving consulting support from Genentech, Sanofi-Aventis, and Novartis; grant support from Biokier, Novartis, and GI Dynamics; personal fees from VTV therapeutics; and grants from XOMA. Dr Ahmed reported receiving institutional grant support from Medtronic. Dr Billington reported receiving institutional grant support from Medtronic, the NIH, and the Department of Veterans Affairs, and consulting support from Novo Nordisk, Enteromedics, and Optum. No other disclosures are reported.
Funding/Support: The Diabetes Surgery Study was supported by Medtronic Inc, formerly Covidien, Mansfield, Massachusetts. Medtronic provided funds for University of Minnesota, Mayo Clinic, Columbia University, National Taiwan University Hospital, and Min-Sheng General Hospital, Taoyuan, Taiwan. This study was supported in part by grants UL1 TR000040 and 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. Support was provided by NIH grant P30 DK50456 to the Minnesota Obesity Center at the University of Minnesota and the Mayo Clinic.