Journal Club Estruch R Ros E SalasSalvad J
Journal Club Estruch R, Ros E, Salas-Salvadó J, Covas MI, D Pharm, Corella D, Arós F, Gómez. Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González MA; the PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N Engl J Med. 2013 Feb 25. [Epub ahead of print] Phillip M, Battelino T, Atlas E, Kordonouri O, Bratina N, Miller S, Biester T, Stefanija MA, Muller I, Nimri R, Danne T. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013 Feb 28; 368(9): 824 -33. 2013年 3月14日 8: 30 -8: 55 8階 医局 埼玉医科大学 総合医療センター 内分泌・糖尿病内科 Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University 松田 昌文 Matsuda, Masafumi
Original Article Weight Loss with a Low-Carbohydrate, Mediterranean, or Low-Fat Diet Israel, Germany, Boston Iris Shai, R. D. , Ph. D. , Dan Schwarzfuchs, M. D. , Yaakov Henkin, M. D. , Danit R. Shahar, R. D. , Ph. D. , Shula Witkow, R. D. , M. P. H. , Ilana Greenberg, R. D. , M. P. H. , Rachel Golan, R. D. , M. P. H. , Drora Fraser, Ph. D. , Arkady Bolotin, Ph. D. , Hilel Vardi, M. Sc. , Osnat Tangi-Rozental, B. A. , Rachel Zuk-Ramot, R. N. , Benjamin Sarusi, M. Sc. , Dov Brickner, M. D. , Ziva Schwartz, M. D. , Einat Sheiner, M. D. , Rachel Marko, M. Sc. , Esther Katorza, M. Sc. , Joachim Thiery, M. D. , Georg Martin Fiedler, M. D. , Matthias Blüher, M. D. , Michael Stumvoll, M. D. , Meir J. Stampfer, M. D. , Dr. P. H. , for the Dietary Intervention Randomized Controlled Trial (DIRECT) Group In this 2 -year trial, we randomly assigned 322 moderately obese subjects (mean age, 52 years; mean body-mass index [the weight in kilograms divided by the square of the height in meters], 31; male sex, 86%) to one of three diets: low-fat, restricted-calorie; Mediterranean, restricted-calorie; or low-carbohydrate, non– restricted-calorie. Shai I et al. N Engl J Med 2008; 359: 229 -241
Weight Changes during 2 Years According to Diet Group Shai I et al. N Engl J Med 2008; 359: 229 -241
Changes in Cholesterol and Triglyceride Biomarkers According to Diet Group during the Maximum Weight-Loss Phase (1 to 6 Months) and the Weight-Loss Maintenance Phase (7 to 24 Months) of the 2 -Year Intervention Shai I et al. N Engl J Med 2008; 359: 229 -241
Changes in Biomarkers According to Diet Group and Presence or Absence of Type 2 Diabetes • Mediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets • The more favorable effects on lipids (with the low-carbohydrate diet) and on glycemic control (with the Mediterranean diet) suggest that personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions Shai I et al. N Engl J Med 2008; 359: 229 -241
Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (R. E. , E. R. , J. S. -S. , M. -I. C. , D. C. , M. F. , J. L. , R. M. L. -R. , J. B. , J. V. S. , J. A. M. ) and the PREDIMED (Prevención con Dieta Mediterránea) Network (RD 06/0045) (R. E. , J. S. -S. , F. A. , E. G. -G. , V. R. -G. , R. M. L. -R. , L. S. -M. , X. P. , J. B. , J. V. S. , J. A. M. , M. A. M. -G. ), Instituto de Salud Carlos III, Madrid; the Department of Internal Medicine (R. E. ) and Lipid Clinic, Department of Endocrinology and Nutrition (E. R. ), Institut d’Investigacions Biomèdiques August Pi I Sunyer, Hospital Clinic, University of Barcelona, Barcelona; Human Nutrition Department, Hospital Universitari Sant Joan, Institut d’Investigació Sanitaria Pere Virgili, Universitat Rovira i Virgili, Reus (J. S. -S. ); Cardiovascular and Nutrition Research Group, Institut de Recerca Hospital del Mar, Barcelona (M. -I. C. ); the Department of Preventive Medicine, University of Valencia, Valencia (D. C. ); the Department of Cardiology, University Hospital of Alava, Vitoria (F. A. ); the Department of Preventive Medicine, University of Malaga, Malaga (E. G. -G. ); Instituto de la Grasa, Consejo Superior de Investigaciones Cientificas, Seville (V. R. -G. ); Institute of Health Sciences (IUNICS), University of Balearic Islands, and Hospital Son Espases, Palma de Mallorca (M. F. ); the Department of Family Medicine, Primary Care Division of Seville, San Pablo Health Center, Seville (J. L. ); the Department of Nutrition and Food Science, School of Pharmacy, Xarxa de Referència en Tecnologia dels Aliments, Instituto de Investigación en Nutrición y Seguridad Alimentaria, University of Barcelona, Barcelona (R. M. L. -R. ); the Department of Clinical Sciences, University of Las Palmas de Gran Canaria, Las Palmas (L. S. -M. ); Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona (X. P. ); Primary Care Division, Catalan Institute of Health, Institut d’Investigació en Atenció Primària Jordi Gol, Tarragona-Reus (J. B. ) and Barcelona (M. A. M. ); Primary Care Division, Valencia Institute of Health, Valencia (J. V. S. ); and the Departments of Nutrition and Food Sciences, Physiology and Toxicology (J. A. M. ) and Preventive Medicine and Public Health (M. A. M. -G. ), University of Navarra, Pamplona — all in Spain. N Engl J Med 2013. DOI: 10. 1056/NEJMoa 1200303
Background Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events.
Methods In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extravirgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4. 8 years.
Figure 1. Kaplan–Meier Estimates of the Incidence of Outcome Events in the Total Study Population. Panel A shows the incidence of the primary end point (a composite of acute myocardial infarction, stroke, and death from cardiovascular causes). CI denotes confidence interval, EVOO extra-virgin olive oil, and Mediterranean.
Figure 1. Kaplan–Meier Estimates of the Incidence of Outcome Events in the Total Study Population. Panel B shows total mortality. Hazard ratios were stratified according to center (Cox model with robust variance estimators). CI denotes confidence interval, EVOO extra-virgin olive oil, and Mediterranean.
Figure 2. Results of Subgroup Analyses. Shown are adjusted hazard ratios for the primary end point within specific subgroups. Squares denote hazard ratios; horizontal lines represent 95% confidence intervals. Hazard ratios indicate the relative risk in both intervention groups merged together (vs. the control group) within each stratum. Hazard ratios were stratified according to recruiting center and were adjusted for sex, age (continuous variable), family history of premature coronary heart disease (CHD) (yes or no), smoking (never smoked, former smoker, or current smoker), body-mass index (BMI) (continuous variable), waist-to-height ratio (continuous variable), hypertension at baseline (yes or no), dyslipidemia at baseline (yes or no), and diabetes at baseline (yes or no). Scores for adherence to the Mediterranean diet range from 0 to 14, with higher scores indicating greater adherence.
Results A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0. 70 (95% confidence interval [CI], 0. 54 to 0. 92) and 0. 72 (95% CI, 0. 54 to 0. 96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported.
Conclusions Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government’s Instituto de Salud Carlos III and others; Controlled-Trials. com number, ISRCTN 35739639. )
the International Diabetes Center at Park Nicollet, Minneapolis (R. M. B. ); Yale University, New Haven, CT (W. V. T. ); Oregon Health and Science University, Portland (A. A. ); University of North Carolina School of Medicine, Chapel Hill ( J. B. B. ); Scripps Institute, La Jolla (G. D. ), and Medtronic, Northridge (T. P. , J. B. W. ) — both in California; University of Maryland School of Medicine, Baltimore (S. N. D. ); Memorial University of Newfoundland, Health Science Centre, St. John’s, NL, Canada (C. J. ); Toronto General Hospital, Toronto (B. A. P. ); Children’s Hospital of Philadelphia, Philadelphia (S. M. W. ); and Helen De. Vos Children’s Hospital, Grand Rapids, MI (M. A. W. ). The rate of severe hypoglycemia in the pump-therapy group (13. 31 cases per 100 person-years) did not differ significantly from that in the injection- therapy group (13. 48 per 100 person-years, P = 0. 58). The Mini. Med Paradigm REAL-Time System is comprised of six components: 1) the Paradigm® 722 insulin pump (MMT-722), 2) the Mini. Link™ REAL-Time transmitter (MMT- 7703) with charger (MMT 7705), 3) the glucose sensor (MMT-7002/7003), 4) the Paradigm® Link glucose meter, 5) the Com. Link (MMT-7304), and 6) a Personal Computer 10. 1056/nejmoa 1002853 nejm. org
the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center of Israel, Petah Tikva (M. P. , E. A. , S. M. , I. M. , R. N. ), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M. P. ) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children’s Hospital, and Faculty of Medicine, University of Ljubljana, Slovenia (T. Battelino, N. B. , M. A. S. ); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O. K. , T. Biester, T. D. ). N Engl J Med 2013; 368: 824 -33.
Background Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.
Methods In this multicenter, multinational, randomized, crossover trial, we assessed the short term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp. In two consecutive overnight sessions, we randomly assigned 56 patients to receive treatment with an artificial pancreas on the first night and a sensor-augmented insulin pump (control) on the second night or to the reverse order of therapies on the first and second nights. Thus, all the patients received each treatment in a randomly assigned order. The primary end points were the number of hypoglycemic events (defined as a sensor glucose value of <63 mg per deciliter [3. 5 mmol per liter] for at least 10 consecutive minutes), the time spent with glucose levels below 60 mg per deciliter (3. 3 mmol per liter), and the mean overnight glucose level for individual patients.
Figure 1. Glycemic Control in the Two Study Treatments. The upper graphs show the sensor glucose profiles during the nights when the artificial pancreas was used (Panel A) and during the nights when the sensor-augmented insulin pump (control) was used (Panel B), and the middle and lower graphs show the respective profiles for basal and bolus insulin infusions. In the upper graphs, the solid black lines indicate the median glucose levels, and the two dashed lines indicate the interquartile range. The circles indicate the median capillary glucose measurements taken every 3 hours during the overnight sessions (11 p. m. to 7 a. m. ), and the vertical lines indicate the interquartile ranges. The horizontal dashed lines indicate glucose measurements of 63 mg per deciliter, 140 mg per deciliter, and 180 mg per deciliter. In the middle graphs, the mean basal rates of insulin infusion are indicated by solid black lines, with dashed lines indicating the ranges. In the bottom panels, the total amounts of insulin delivered over time as bolus doses are indicated by the vertical black lines with circles. To convert the values for glucose to millimoles per liter, multiply by 0. 05551.
Results On nights when the artificial pancreas was used, versus nights when the sensoraugmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels below 63 mg per deciliter (7 vs. 22) and significantly shorter periods when glucose levels were below 60 mg per deciliter (P = 0. 003 and P = 0. 02, respectively, after adjustment for multiplicity). Median values for the individual mean overnight glucose levels were 126. 4 mg per deciliter (interquartile range, 115. 7 to 139. 1 [7. 0 mmol per liter; interquartile range, 6. 4 to 7. 7]) with the artificial pancreas and 140. 4 mg per deciliter (interquartile range, 105. 7 to 167. 4 [7. 8 mmol per liter; interquartile range, 5. 9 to 9. 3]) with the sensoraugmented pump. No serious adverse events were reported.
Conclusions Patients at a diabetes camp who were treated with an artificial -pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump. (Funded by Sanofi and others; Clinical. Trials. gov number, NCT 01238406. )
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