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These participants were randomly assigned to one of three eating plans: Med-EatPlan supplemented with extra-virgin olive oil (EVOO), Med-EatPlan supplemented with mixed nuts, or a low-fat eating plan (control). In a subgroup (15%), the allocation was done in small clusters instead of using individual randomization, and the clustering effect was taken into account in the statistical analysis. In multivariable time-to-event survival models, we assessed two outcomes: 1) introduction of the first glucose-lowering medication (oral or injectable) among participants on lifestyle management at enrollment and 2) insulin initiation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>After a median follow-up of 3.2 years, in multivariable analyses adjusting for baseline characteristics and propensity scores, the hazard ratios (HRs) of starting a first glucose-lowering medication were 0.78 (95% CI 0.62\u20130.98) for Med-EatPlan + EVOO and 0.89 (0.71\u20131.12) for Med-EatPlan + nuts, compared with the control eating plan. After a median follow-up of 5.1 years, the adjusted HRs of starting insulin treatment were 0.87 (0.68\u20131.11) for Med-EatPlan + EVOO and 0.89 (0.69\u20131.14) for Med-EatPlan + nuts compared with the control eating plan.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>Among participants with type 2 diabetes, a Med-EatPlan + EVOO may delay the introduction of new-onset glucose-lowering medications. The Med-EatPlan did not result in a significantly lower need for insulin.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc18-2475","type":"journal-article","created":{"date-parts":[[2019,6,14]],"date-time":"2019-06-14T22:55:11Z","timestamp":1560552911000},"page":"1390-1397","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":54,"title":["Effects of a Mediterranean Eating Plan on the Need for Glucose-Lowering Medications in Participants With Type 2 Diabetes: A Subgroup Analysis of the PREDIMED Trial"],"prefix":"10.2337","volume":"42","clinical-trial-number":[{"clinical-trial-number":"isrctn35739639","registry":"10.18810\/isrctn"}],"author":[{"given":"F. Javier","family":"Basterra-Gortari","sequence":"first","affiliation":[{"name":"Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain"},{"name":"Department of Internal Medicine (Endocrinology), Hospital Reina Sofia, Tudela, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7684-2787","authenticated-orcid":false,"given":"Miguel","family":"Ruiz-Canela","sequence":"additional","affiliation":[{"name":"Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain"},{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3917-9808","authenticated-orcid":false,"given":"Miguel A.","family":"Mart\u00ednez-Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain"},{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Babio","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Universitat Rovira i Virgili, Department Biochemistry and Biotechnology, Human Nutrition Unit, IISPV, Reus, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 V.","family":"Sorl\u00ed","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Department of Preventive Medicine, University of Valencia, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Montserrat","family":"Fito","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilio","family":"Ros","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Lipid Clinic, Endocrinology and Nutrition Service, Institut d\u2019investigacions Biom\u00e8diques August Pi i Sunyer (IDIBAPS), Hospital Cl\u00ednic, University of Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"G\u00f3mez-Gracia","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Department of Preventive Medicine, University of Malaga, Malaga, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miquel","family":"Fiol","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Institute of Health Sciences, University of Balearic Islands and Son Espases Hospital, Palma de Mallorca, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9","family":"Lapetra","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Department of Family Medicine, Research Unit, Distrito Sanitario Atenci\u00f3n Primaria Sevilla, Sevilla, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ram\u00f3n","family":"Estruch","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Department of Internal Medicine, Institut d\u2019investigacions Biom\u00e8diques August Pi i Sunyer (IDIBAPS), Hospital Cl\u00ednic, University of Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Serra-Majem","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Instituto Universitario de Investigaciones Biom\u00e9dicas y Sanitarias (IUIBS), Universidad de Las Palmas de Gran Canaria, and Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI), Servicio Canario de Salud, Las Palmas de Gran Canaria, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Pinto","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Lipid Unit, Department of Internal Medicine, Bellvitge Biomedical Research Institute-Hospital Universitari de Bellvitge, L\u2019Hospitalet de Llobregat, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 I.","family":"Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Department of Preventive Medicine, University of Valencia, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0218-7046","authenticated-orcid":false,"given":"M\u00f3nica","family":"Bull\u00f3","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Universitat Rovira i Virgili, Department Biochemistry and Biotechnology, Human Nutrition Unit, IISPV, Reus, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Casta\u00f1er","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1ngel","family":"Alonso-G\u00f3mez","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Department of Cardiology, University Hospital Araba, Vitoria, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Forga","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nutrition, Complejo Hospitalario de Navarra, Instituto de investigaci\u00f3n Sanitaria de Navarra (IdiSNA), Pamplona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8337-7185","authenticated-orcid":false,"given":"Fernando","family":"Ar\u00f3s","sequence":"additional","affiliation":[{"name":"Consorcio CIBER, M.P. Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain"},{"name":"Department of Cardiology, University Hospital Araba, Vitoria, Spain"},{"name":"University of the Basque Country UPV\/EHU, Vitoria-Gasteiz, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2019,6,10]]},"reference":[{"key":"2022031300184167900_B1","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1016\/j.diabres.2018.02.023","article-title":"IDF Diabetes Atlas: global estimates of diabetes prevalence for 2017 and projections for 2045","volume":"138","author":"Cho","year":"2018","journal-title":"Diabetes Res Clin Pract"},{"key":"2022031300184167900_B2","doi-asserted-by":"crossref","first-page":"k1497","DOI":"10.1136\/bmj.k1497","article-title":"Prevalence of diagnosed type 1 and type 2 diabetes among US adults in 2016 and 2017: population based study","volume":"362","author":"Xu","year":"2018","journal-title":"BMJ"},{"key":"2022031300184167900_B3","doi-asserted-by":"crossref","first-page":"837","DOI":"10.1016\/S0140-6736(98)07019-6","article-title":"Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)","volume":"352","author":"UK Prospective Diabetes Study (UKPDS) Group","year":"1998","journal-title":"Lancet"},{"key":"2022031300184167900_B4","doi-asserted-by":"crossref","first-page":"2427","DOI":"10.1056\/NEJMoa066224","article-title":"Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy","volume":"355","author":"Kahn","year":"2006","journal-title":"N Engl J Med"},{"key":"2022031300184167900_B5","doi-asserted-by":"crossref","first-page":"2005","DOI":"10.1001\/jama.281.21.2005","article-title":"Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49)","volume":"281","author":"Turner","year":"1999","journal-title":"JAMA"},{"key":"2022031300184167900_B6","doi-asserted-by":"crossref","first-page":"S120","DOI":"10.2337\/dc14-S120","article-title":"Nutrition therapy recommendations for the management of adults with diabetes","volume":"37","author":"Evert","year":"2014","journal-title":"Diabetes Care"},{"key":"2022031300184167900_B7","doi-asserted-by":"crossref","first-page":"2669","DOI":"10.2337\/dci18-0033","article-title":"Management of hyperglycemia in type 2 diabetes, 2018. 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