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To assess the long-term effectiveness of a pragmatic public healthcare strategy to prevent type 2 diabetes within primary care setting. In the extended follow-up of the DEPLANCAT project, we explored whether the originally-achieved risk reduction remains after discontinuation of active lifestyle intervention. Middle-aged men (n=184) and women (n=368) with Finnish Diabetes Risk Score (FINDRISC)>14 and/or prediabetes (WHO rules for fasting or 2-h glucose) were allocated not randomly but sequentially to standard care control (CG) or intensive lifestyle intervention (IG) group. After a median of 4.2 y of active intervention, participants who were still free of diabetes were further followed-up without any additional specific intervention for a median of 5.8 y (median total follow-up of 10.01 y) via computerized health-care records or direct personal contact with invitation to 2h-glucose retest. The primary outcome was the development of diabetes. During the active intervention, diabetes was diagnosed in 124 participants (22.5%): 63 (28.8%) in the CG and 61 (18.3%) in the IG. After 10 y, 27 people (4.9%) had died. Among the remaining 401 individuals, 34 diabetes diagnoses were traced using the health-care records. Additionally, among the 191 people (47.6%) who agreed to blood re-test (66 in the CG and 125 in the IG) 16 new cases were found. During the post-intervention follow-up the total number of new cases of diabetes was 16 in the CG and 34 in the IG. The absolute incidences of diabetes during the overall follow-up were 6.1 (95% CI 5.2-6.9) and 5.1 (4.4-5.8) per 100 person-years, respectively (p=0.019 log-rank). The corresponding HR was 0.59 (0.43-0.81) with a relative risk reduction of 16.6%. The NNT to prevent one case of diabetes was 10. Intensive lifestyle intervention in a primary care setting substantially reduces diabetes incidence among high-risk individuals. Risk reduction can persist for at least 10 years. Disclosure F. Barrio: None. B. Costa: None. F. Cos: None. J. Cabre: None. A. Martinez: None. S. Mestre: None. C. Castell: None. J. Lindstrom: None. Funding Institute of Health Carlos III, Spanish Ministry of Health and the European Regional Development Fund (PI14/00122, PI14/00124); La Marató de TV3 Foundation (73-201609.10); Spanish Diabetes Society; Department of Health, Generalitat de Catalunya; Pla Estratègic de Recerca i Innovació en Salut (SLT002/16/00045, SLT002/16/00154, SLT002/16/00093)

Background & aims: Legumes, a low-energy, nutrient-dense and low glycemic index food, have shown beneficial effects on glycemic control and adiposity. As such, legumes are widely recommended in diabetic diets, even though there is little evidence that their consumption protects against type 2 diabetes. Therefore the aim of the present study was to examine the associations between consumption of total legumes and specific subtypes, and type 2 diabetes risk. We also investigated the effect of theoretically substituting legumes for other protein- or carbohydrate-rich foods. Methods: Prospective assessment of 3349 participants in the PREvención con DIeta MEDiterránea (PREDIMED) study without type 2 diabetes at baseline. Dietary information was assessed at baseline and yearly during follow-up. We used Cox regression models to estimate hazard ratios (HRs) and 95% confidence intervals (95% CIs) for type-2 diabetes incidence according to quartiles of cumulative average consumption of total legumes, lentils, chickpeas, dry beans and fresh peas. Results: During a median follow-up of 4.3 years, 266 new cases of type 2 diabetes occurred. Individuals in the highest quartile of total legume and lentil consumption had a lower risk of diabetes than those in the lowest quartile (HR: 0.65; 95% CI: 0.43, 0.96; P-trend = 0.04; and HR: 0.67; 95% CI: 0.46–0.98; P-trend = 0.05, respectively). A borderline significant association was also observed for chickpeas consumption (HR 0.68; 95% CI: 0.46, 1.00; P-trend = 0.06). Substitutions of half a serving/day of legumes for similar servings of eggs, bread, rice or baked potato was associated with lower risk of diabetes incidence. Conclusions: A frequent consumption of legumes, particularly lentils, in the context of a Mediterranean diet, may provide benefits on type 2 diabetes prevention in older adults at high cardiovascular risk. Trial registration: The trial is registered at http://www.controlled-trials.com (ISRCTN35739639). Registration date: 5th October 2005., The authors disclose no conflict of interest related with the article. Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN) is an initiative of the Instituto de Salud Carlos III (ISCIII) of Spain which is supported by FEDER funds (CB06/03). Supported by the official funding agency for biomedical research of the Spanish government, ISCIII, through grants provided to research networks specifically developed for the trial (RTIC G03/140 and RD 06/0045) through CIBEROBN, and by grants from Centro Nacional de Investigaciones Cardiovasculares (CNIC 06/2007), Fondo de Investigación Sanitaria–FondoEuropeo de Desarrollo Regional (PI04–2239, PI05/2584, CP06/00100, PI07/0240, PI07/1138, PI07/0954, PI 07/0473, PI10/01407, PI10/02658, PI11/01647, and PI11/02505; PI13/00462), Ministerio de Ciencia e Innovación (AGL-2009–13906-C02 and AGL2010–22319-C03), Fundación Mapfre 2010, Consejería de Salud de la Junta de Andalucía (PI0105/2007), Public Health Division of the Department of Health of the Autonomous Government of Catalonia, Generalitat Valenciana (ACOMP06109, GVA-COMP2010–181, GVACOMP2011–151, CS2010-AP-111, and CS2011-AP-042), and the Navarra Regional Government (27/2011). The Fundación Patrimonio Comunal Olivarero and Hojiblanca SA (Málaga, Spain), California Walnut Commission (Sacramento, CA), Borges SA (Reus, Spain), and Morella Nuts SA (Reus, Spain) donated the olive oil, walnuts, almonds, and hazelnuts, respectively, used in the study. None of the funding sources played a role in the design, collection, analysis or interpretation of the data or in the decision to submit the manuscript for publication. Acknowledgements: The authors thank all the participants for their collaboration, all the PREDIMED personnel for their assistance and all the personnel of affiliated primary care centers for making the study possible. CIBEROBN is an initiative of ISCIII, Spain.

Objective To derive and validate a set of functions to predict coronary heart disease (CHD) and stroke, and validate the Framingham-REGICOR function. Method Pooled analysis of 11 population-based Spanish cohorts (1992–2005) with 50,408 eligible participants. Baseline smoking, diabetes, systolic blood pressure (SBP), lipid profile, and body mass index were recorded. A ten-year follow-up included re-examinations/telephone contact and cross-linkage with mortality registries. For each sex, two models were fitted for CHD, stroke, and both end-points combined: model A was adjusted for age, smoking, and body mass index and model B for age, smoking, diabetes, SBP, total and HDL cholesterol, and for hypertension treatment by SBP, and age by smoking and by SBP interactions. Results The 9.3-year median follow-up accumulated 2973 cardiovascular events. The C-statistic improved from model A to model B for CHD (0.66 to 0.71 for men; 0.70 to 0.74 for women) and the combined CHD-stroke end-points (0.68 to 0.71; 0.72 to 0.75, respectively), but not for stroke alone. Framingham-REGICOR had similar C-statistics but overestimated CHD risk. Conclusions The new functions accurately estimate 10-year stroke and CHD risk in the adult population of a typical southern European country. The Framingham-REGICOR function provided similar CHD prediction but overestimated risk.

Background and aims Transferring the results from clinical trials on type 2 diabetes prevention is the objective of the Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional intervention (DE-PLAN) project in Catalonia, whose cost-effectiveness analysis is now presented. Patients and methods A prospective cohort study was performed in primary care involving individuals without diagnosed diabetes aged 45–75 years (n = 2054) screened using the questionnaire Finnish Diabetes Risk Score (FINDRISC) and a subsequent oral glucose tolerance test. Where feasible, high-risk individuals who were identified (n = 552) were allocated sequentially to standard care (n = 219), a group-based (n = 230) or an individual-level (n = 103) intensive (structured programme of 6 h using specific teaching techniques) lifestyle intervention (n = 333). The primary outcome was the development of diabetes (WHO). We evaluated the cost of resources used with comparison of standard care and the intervention groups in terms of effectiveness and quality of life (15D questionnaire). Results After 4.2-year median follow-up, the cumulative incidences were 18.3% (14.3–22.9%) in the intensive intervention group and 28.8% (22.9–35.3%) in the standard care group (36.5% relative-risk-reduction). The corresponding 4-year HR was 0.64 (0.47–0.87; P

To assess the feasibility and effectiveness of an active real-life primary care lifestyle intervention in preventing type 2 diabetes within a high-risk Mediterranean population.A prospective cohort study was performed in the setting of Spanish primary care. White-European individuals without diabetes aged 45-75 years (n = 2,054) were screened using the Finnish Diabetes Risk Score (FINDRISC) and a subsequent 2 h OGTT. Where feasible, high-risk individuals who were identified were allocated sequentially to standard care, a group-based or an individual level intervention (intensive reinforced DE-PLAN [Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional] intervention). The primary outcome was the development of diabetes according to WHO criteria. Analyses after 4-year follow-up were performed based on the intention-to-treat principle with comparison of standard care and the combined intervention groups.The standard care (n = 219) and intensive intervention (n = 333) groups were comparable in age (62.0/62.2 years), sex (64.4/68.2% women), BMI (31.3/31.2 kg/m(2)), FINDRISC score (16.2/15.8 points), fasting (5.3/5.2 mmol/l), 2 h plasma glucose (7.1/6.9 mmol/l) and self-reported interest to make lifestyle changes at baseline. Diabetes was diagnosed in 124 individuals: 63 (28.8%) in the standard care group and 61 (18.3%) in the intensive intervention group. During a 4.2-year median follow-up, the incidences of diabetes were 7.2 and 4.6 cases per 100 person-years, respectively (36.5% relative risk reduction, p0.005). The number of participants needed to be treated by intensive intervention for 4 years to reduce one case of diabetes was 9.5.Intensive lifestyle intervention is feasible in a primary care setting and substantially reduces diabetes incidence among high-risk individuals.ClinicalTrial.gov NCT01519505.Commission of the European Communities, Institute of Health Carlos III, Spanish Ministry of Health and Department of Health, Generalitat de Catalunya.

Diabet. Med. 28, 1234–1237 (2011) Abstract Aim To investigate changes in the prevalence of diabetes and pre-diabetes by shifting from 2-h plasma glucose and/or fasting plasma glucose diagnostic criteria to the proposed new HbA1c-based criteria when applied to a Mediterranean population detected to have a high risk of Type 2 diabetes. Methods Individuals without diabetes aged 45–75 years (n = 2287) were screened using the Finnish Diabetes Risk Score questionnaire, a 2-h oral glucose tolerance test plus HbA1c test. Prevalence and degree of diagnostic overlap between three sets of criteria (2-h plasma glucose, fasting plasma glucose and HbA1c) and three diagnostic categories (normal, pre-diabetes and diabetes) were calculated. Results Defining diabetes by a single HbA1c measurement resulted in a dramatic decrease in prevalence (1.3%), particularly in comparison with diabetes defined by 2-h plasma glucose (8.6%), but was also significant with regard to fasting plasma glucose (2.8%). A total of 201 screened subjects (8.8%) were classified as having diabetes and 1023 (44.7%) as having pre-diabetes based on at least one of these criteria; among these, the presence of all three criteria simultaneously classified only 21 and 110 individuals respectively, about ten percent of each group. The single overlap index between subjects diagnosed as having diabetes by 2-h plasma glucose/fasting plasma glucose vs. HbA1c was 13.9/28%. Similarly, the single overlap index regarding pre-diabetes was 19.2/27.1%. Conclusions A shift from the glucose-based diagnosis to the HbA1c-based diagnosis for diabetes will reduce diabetes prevalence with a low overall or single degree of overlap between diagnostic categories in this high-risk Spanish population.

To assess the relevance of unrecognized hyperglycemia among high-risk subjects for developing diabetes a cross-sectional study was carried out. Subjects aged 40–75 years with (high-risk group) and without (control group) history of impaired glucose metabolism underwent a 2 h-oral glucose tolerance test (OGTT). All individuals with diabetes diagnostic criteria and all controls with glucose abnormalities at OGTT were excluded. An individualized 48-h continuous glucose monitoring (CGM) calibrated by fasting plasma glucose was performed. The microdialysis-based biosensor recordings were computerized in order to identify continuous glucose profiles. Of the 121 monitored subjects, 104 were finally analyzed (56.7% female, 57.8 years, BMI = 29.2, A1C = 4.9%, HOMA index = 2.5). Glucose profiles corresponded to 31 controls (29.8%), 32 high-risk individuals with normal OGTT (30.8%) and 41 (39.4%) with hyperglycemia at OGTT. The recordings defined as hyperglycemia (fasting ≥6.1 mmol/l, non-fasting ≥7.8 mmol/l) appeared during an average of 1.4 h, 4.9 h and 7.6 h (3.9%, 13.9% and 19% of the CGM time), respectively. The highest percentage of impaired CGM registers corresponded to the fasting period. Nevertheless, the longest duration corresponded to the non-fasting period. The CGM evidenced a relevant degree of casual undetected hyperglycaemia among high-risk individuals.