End-of-Trial Health Outcomes in Look AHEAD Participants who Elected to have Bariatric Surgery

the Look AHEAD Research Group

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Objective: This study examined end-of-trial health outcomes in participants in the Action for Health in Diabetes (Look AHEAD) trial who had bariatric surgery during the approximately 10-year randomized intervention. Methods: Data were obtained from the Look AHEAD public access database of 4,901 individuals with type 2 diabetes and overweight/obesity who were assigned to intensive lifestyle intervention (ILI) or a diabetes support and education (DSE) control group. Changes in outcomes in participants who had bariatric surgery were compared with those in participants with BMI ≥ 30 kg/m 2 who remained in the ILI and DSE groups. Results: A total of 99 DSE and 97 ILI participants had bariatric surgery. At randomization, these 196 participants were significantly younger and more likely to be female and to have higher BMI than the remaining ILI (N = 1,972) and DSE (N = 2,009) participants. At trial’s end, surgically treated participants lost 19.3% of baseline weight, compared with 5.8% and 3.3% for the ILI and DSE groups, respectively, and were more likely to achieve partial or full remission of their diabetes. Conclusions: The large, sustained improvements in weight and diabetes observed in this self-selected sample of surgically treated participants are consistent with results of multiple randomized trials.

Original languageEnglish (US)
Pages (from-to)581-590
Number of pages10
JournalObesity
Volume27
Issue number4
DOIs
StatePublished - Apr 2019

Bibliographical note

Funding Information:
agencies: This study was supported by the Department of Health and Human Services through the following cooperative agreements from the National Institutes of Health: DK57136, DK57149, DK56990, DK57177, DK57171, DK57151, DK57182, DK57131, DK57002, DK57078, DK57154, DK57178, DK57219, DK57008, DK57135, and DK56992. The following federal agencies have contributed support: National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Institute of Nursing Research; National Center on Minority Health and Health Disparities; National Institutes of Health Office of Research on Women’s Health; and the Centers for Disease Control and Prevention. This research was supported in part by the Intramural Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases. The Indian Health Service provided personnel, medical oversight, and use of facilities. Additional support was received from the Johns Hopkins Medical Institutions Bayview General Clinical Research Center (M01RR02719), the Massachusetts General Hospital Mallinckrodt General Clinical Research Center, and the Massachusetts Institute of Technology General Clinical Research Center (M01RR01066); the University of Colorado Health Sciences Center General Clinical Research Center (M01RR00051) and Clinical Nutrition Research Unit (P30 DK48520); the University of Tennessee at Memphis General Clinical Research Center (M01RR0021140); the University of Pittsburgh General Clinical Research Center (M01RR000056); the Clinical Translational Research Center funded by the Clinical and Translational Science Award (UL1 RR 024153) and a National Institutes of Health grant (DK 046204); the Veterans Affairs Puget Sound Health Care System Medical Research Service, Department of Veterans Affairs; and the Frederic C. Bartter General Clinical Research Center (M01RR01346). Some of the information contained herein was derived from data provided by the Bureau of Vital Statistics, New York City Department of Health and Mental Hygiene. Federal support was provided by the National Institute of Diabetes and Digestive and Kidney Diseases (Mary Evans, Barbara Harrison, Van Hubbard, and Susan Z. Yanovski); the National Heart, Lung, and Blood Institute (to Lawton S. Cooper, Peter Kaufman, and Mario Stylianou); and the Centers for Disease Control and Prevention (to Edward Gregg and Ping Zhang). AMC’s efforts were supported by the National Institute of Nursing Research of the National Institutes of Health under award number K23NR017209.This paper is dedicated to the memory of G. L. Blackburn, MD, PhD. For participants who provided informed consent, their deidentified data from the Look AHEAD trial are available through the NIDDK Central Repository (https://repository.niddk.nih.gov/pages/archive/). This site includes the study protocol, the analysis plan, study forms, and detailed descriptions of the data.

Funding Information:
See Commentary, pg. 534. Funding agencies: This study was supported by the Department of Health and Human Services through the following cooperative agreements from the National Institutes of Health: DK57136, DK57149, DK56990, DK57177, DK57171, DK57151, DK57182, DK57131, DK57002, DK57078, DK57154, DK57178, DK57219, DK57008, DK57135, and DK56992. The following federal agencies have contributed support: National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Institute of Nursing Research; National Center on Minority Health and Health Disparities; National Institutes of Health Office of Research on Women’s Health; and the Centers for Disease Control and Prevention. This research was supported in part by the Intramural Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases. The Indian Health Service provided personnel, medical oversight, and use of facilities. Additional support was received from the Johns Hopkins Medical Institutions Bayview General Clinical Research Center (M01RR02719), the Massachusetts General Hospital Mallinckrodt General Clinical Research Center, and the Massachusetts Institute of Technology General Clinical Research Center (M01RR01066); the University of Colorado Health Sciences Center General Clinical Research Center (M01RR00051) and Clinical Nutrition Research Unit (P30 DK48520); the University of Tennessee at Memphis General Clinical Research Center (M01RR0021140); the University of Pittsburgh General Clinical Research Center (M01RR000056); the Clinical Translational Research Center funded by the Clinical and Translational Science Award (UL1 RR 024153) and a National Institutes of Health grant (DK 046204); the Veterans Affairs Puget Sound Health Care System Medical Research Service, Department of Veterans Affairs; and the Frederic C. Bartter General Clinical Research Center (M01RR01346). Some of the information contained herein was derived from data provided by the Bureau of Vital Statistics, New York City Department of Health and Mental Hygiene. Federal support was provided by the National Institute of Diabetes and Digestive and Kidney Diseases (Mary Evans, Barbara Harrison, Van Hubbard, and Susan Z. Yanovski); the National Heart, Lung, and Blood Institute (to Lawton S. Cooper, Peter Kaufman, and Mario Stylianou); and the Centers for Disease Control and Prevention (to Edward Gregg and Ping Zhang). AMC’s efforts were supported by the National Institute of Nursing Research of the National Institutes of Health under award number K23NR017209. Disclosure: JMJ reports serving on a scientific advisory board for Weight Watchers, and TAW serves on scientific advisory boards for Novo Nordisk and Weight Watchers. The other authors report no conflicts of interest. Author contributions: Members of the writing group included TAW, AMC, JLB, JPB, JMC, SAG, JMJ, KCJ, GDM, JLU, and SZY. The final draft of the manuscript was reviewed and approved by all members of the writing group and by members of the Look AHEAD Research Group Steering Committee. Clinical trial registration: ClinicalTrials.gov identifier NCT00017953. Additional Supporting Information may be found in the online version of this article. Received: 28 September 2018; Accepted: 20 December 2018; Published online 22 March 2019. doi:10.1002/oby.22411

Publisher Copyright:
© 2019 The Obesity Society

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