1. Journal Club 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 2010 年７月 22 日 8:30-8:55 ８階 医局 The HEALTHY Study Group. A School-Based Intervention for Diabetes Risk Reduction. N Engl J Med. 2010 Jun 27. [Epub ahead of print] Cooper-DeHoff RM, Gong Y, Handberg EM, Bavry AA, Denardo SJ, Bakris GL, Pepine CJ. Tight blood pressure control and cardiovascular outcomes among hypertensive patients with diabetes and coronary artery disease. JAMA. 2010 Jul 7;304(1):61-8.

3. Gary D. Foster, Ph.D., Temple University, Philadelphia; Barbara Linder, M.D., Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; Tom Baranowski, Ph.D., Baylor College of Medicine, Houston; Dan M. Cooper, M.D., University of California at Irvine, Irvine; Linn Goldberg, M.D., Oregon Health and Science University, Portland; Joanne S. Harrell, Ph.D., University of North Carolina at Chapel Hill, Chapel Hill; Francine Kaufman, M.D., Children’s Hospital Los Angeles, Los Angeles; Marsha D. Marcus, Ph.D., University of Pittsburgh, Pittsburgh; Roberto P. Trevino, M.D., University of Texas Health Science Center at San Antonio, San Antonio; and Kathryn Hirst, Ph.D., George Washington University, Washington, DC 10.1056/nejmoa1001933 nejm.org

4. We examined the effects of a multicomponent, school-based program addressing risk factors for diabetes among children whose race or ethnic group and socioeconomic status placed them at high risk for obesity and type 2 diabetes. Background

5. Using a cluster design, we randomly assigned 42 schools to either a multicomponent school- based intervention (21 schools) or assessment only (control, 21 schools). A total of 4603 students participated (mean [±SD] age, 11.3±0.6 years; 54.2% Hispanic and 18.0% black; 52.7% girls). At the beginning of 6th grade and the end of 8th grade, students underwent measurements of body-mass index (BMI), waist circumference, and fasting glucose and insulin levels. Methods

8. INTERVENTION The intervention consisted of four integrated components: nutrition; physical activity; behavioral knowledge and skills; and communications and social marketing. The rationale, techniques, and pilot testing of each component are briefly summarized below. All intervention components lasted for 5 semesters (second semester of 6th grade, both semesters of 7th grade, and both semesters of 8th grade). Each semester’s activities centered on a common theme (e.g., water versus sweetened beverages, physical activity versus sedentary behavior, energy balance).

9. The nutrition component targeted the quantity and nutritional quality of foods and beverages served throughout the school environment (cafeteria, vending, a la carte options, snack bars, school stores, fundraisers, and classroom celebrations). It had five goals: lower the fat content of foods served; provide ≥ 2 fruit and/or vegetable servings per student at lunch and one serving at breakfast; limit dessert and snack foods to ≤ 200 kcal per item; limit beverages to water, ≤ 1% milk, and 100% fruit juice (6 oz limit, only at breakfast or as an after- school snack); and serve ≥ 2 servings of grain-based foods with ≥ 2 g of fiber per serving at lunch and 1 g of fiber per serving at breakfast.

10. The physical education (PE) component was designed to increase the amount of time students spent in moderate-to-vigorous physical activity (MVPA), defined as a heart rate ≥ 130 beats per minute. Intervention schools were required to schedule ≥ 225 minutes of PE over a 10-day period throughout the entire school year in order to achieve the target of ≥ 150 minutes of MVPA per 10 days. This was implemented by the school’s PE teacher and a study-hired aide, using curriculum designed by study staff. The 7 curriculum was consistent with each state’s mandated PE guidelines. Intervention schools were provided with equipment to implement the PE intervention component.

11. Behavioral knowledge and skills were delivered through a classroom-based program, FLASH ( Fun Learning Activities for Student Health ) which targeted awareness, knowledge, behavioral skills (e.g., self-monitoring, goal setting), and peer influence for behavior change. Each semester students received a series of 8-10 FLASH interactive sessions, 30 minutes each, with multiple activities per session delivered by teachers. To enhance parental support of behavior change outside the school, seven newsletters were distributed to parents featuring family vignettes that matched the semester’s theme. In addition, there were two take-home vacation “break” challenges. The first was distributed during the summer between 7th and 8th grade, and the second was distributed before the 8th grade winter break. Each challenge provided parents with information and tools consistent with intervention themes.

12. Communication strategies and social marketing integrated and supported the intervention. Campaigns included: core elements such as branding, posters, and verbal messaging (e.g., in- school announcements); student events (e.g., assemblies) and student-generated media; and distribution of premiums (e.g., t-shirts) and theme incentives (e.g., water bottles, pedometers) to extend the visibility of the intervention beyond the school environment.

13. Intervention Themes and Targeted Behaviors A. THEMES Second Half of 6th Grade Water versus Added Sugar Beverages First Half of 7th Grade Physical Activity versus Sedentary Behavior Second Half of 7th Grade High Quality versus Low Quality Food First Half of 8th Grade Energy Balance: Energy In/Energy Out Second Half of 8th Grade Strength, Balance, and Choice for Life B. TARGETED BEHAVIORS Increasing water consumption Substituting water for added sugar beverages Drinking water for health, nutrition, and hydration Choosing healthier foods and drinks for meals and snacks Substituting nutrient dense, lower caloric foods for low nutrient, higher caloric foods Self-monitoring, goal setting, and problem solving to increase intake of water, fruits, and vegetables Increasing movement and accumulation of time spent being active Decreasing time spent in sedentary behavior Substituting physical activity for sedentary behavior Self-monitoring, goal setting, and problem solving to increase physical activity and decrease sedentary behavior

14. Nutrition/Food Service Intervention Goals (‘served’ refers to items taken by the student, either through sale or subsidized program) Goal I: Lower the average fat content of food served in school. Goal II: Serve at least 2 servings of fruit and/or vegetables per student on NSLP and at least 1 serving per student on NSBP each day Goal III: Serve all dessert snack foods with ≦ 200 calories per single serving size package. Goal IV: Eliminate milk > 1%, all other added sugar beverages, and 100% fruit juice (100% fruit juice may only be served as < 6 ounces [170g] as part of NSBP). Goal V: Serve at least 2 servings of grain-based foods and/or legumes ( ≧ 2 g fiber per serving) per student on NSLP and at least 1 serving per student on NSBP each day. National School Lunch Program (NSLP), National School Breakfast Program (NSBP),

17. Results There was a decrease in the primary outcome — the combined prevalence of overweight and obesity — in both the intervention and control schools, with no significant difference between the school groups. The intervention schools had greater reductions in the secondary outcomes of BMI z score, percentage of students with waist circumference at or above the 90th percentile, fasting insulin levels (P = 0.04 for all comparisons), and prevalence of obesity (P = 0.05). Similar findings were observed among students who were at or above the 85th percentile for BMI at baseline. Less than 3% of the students who were screened had an adverse event; the proportions were nearly equivalent in the intervention and control schools.

18. Conclusion Our comprehensive school-based program did not result in greater decreases in the combined prevalence of overweight and obesity than those that occurred in control schools. However, the intervention did result in significantly greater reductions in various indexes of adiposity. These changes may reduce the risk of childhood- onset type 2 diabetes. (ClinicalTrials.gov number, NCT00458029.)

19. Message 糖尿病の教育は小中学校から？ 手間がかかる割には大きな効果は期待でき そうもない。が、現実に肥満児童や生徒が 増えている！ ⇒ ジャンクフード販売規制とか ソーダ税？

21. Department of Pharmacotherapy and Translational Research, College of Pharmacy (Drs Cooper-DeHoff and Gong) and Division of Cardiovascular Medicine, College of Medicine (Drs Cooper-DeHoff, Handberg, Bavry, Denardo, and Pepine), University of Florida, Gainesville; and Department of Medicine, Hypertensive Diseases Unit, Section of Endocrinology, Diabetes, and Metabolism, University of Chicago-Pritzker School of Medicine, Chicago, Illinois (Dr Bakris). JAMA. 2010;304(1):61-68 International Verapamil SR-Trandolapril Study (INVEST)

22. In 1993, the fifth report of the Joint National Committee recommended that the treatment goal for patients with diabetes should reduce blood pressure (BP) to less than 130/85mmHg. In 2002, the American Diabetes Association recommended that the BP treatment goal for patients with diabetes should be less than 130/80 mm Hg, which it reaffirmed in 2010.

23. Background Context Hypertension guidelines advocate treating systolic blood pressure (BP) to less than 130 mm Hg for patients with diabetes mellitus; however, data are lacking for the growing population who also have coronary artery disease (CAD). Objective To determine the association of systolic BP control achieved and adverse cardiovascular outcomes in a cohort of patients with diabetes and CAD.

24. Design, Setting, and Patients Observational subgroup analysis of 6400 of the 22 576 participants in the International Verapamil SR-Trandolapril Study (INVEST). For this analysis, participants were at least 50 years old and had diabetes and CAD. Participants were recruited between September 1997 and December 2000 from 862 sites in 14 countries and were followed up through March 2003 with an extended follow- up through August 2008 through the National Death Index for US participants. Intervention Patients received first-line treatment of either a calcium antagonist or  -blocker followed by angiotensin- converting enzyme inhibitor, a diuretic, or both to achieve systolic BP of less than 130 and diastolic BP of less than 85 mm Hg. Patients were categorized as having tight control if they could maintain their systolic BP at less than 130 mm Hg; usual control if it ranged from 130 mm Hg to less than 140 mm Hg; and uncontrolled if it was 140 mm Hg or higher.

25. Main Outcome Measures Adverse cardiovascular outcomes, including the primary outcomes which was the first occurrence of all-cause death, nonfatal myocardial infarction, or nonfatal stroke.

27. SysBP < 130130 ≦ SysBP < 140140 ≦ SysBP

31. Results During 16 893 patient-years of follow-up, 286 patients (12.7%) who maintained tight control, 249 (12.6%) who had usual control, and 431 (19.8%) who had uncontrolled systolic BP experienced a primary outcome event. Patients in the usual control group had a cardiovascular event rate of 12.6% vs a 19.8% event rate for those in the uncontrolled group (adjusted hazard ratio [HR], 1.46; 95% confidence interval [CI], 1.25-1.71; P<.001). However, little difference existed between those with usual control and those with tight control. Their respective event rates were 12.6% vs 12.7% (adjusted HR, 1.11; 95% CI, 0.93-1.32; P=.24). The all-cause mortality rate was 11.0% in the tight-control group vs 10.2% in the usual-control group (adjusted HR, 1.20; 95% CI, 0.99-1.45; P=.06); however, when extended follow-up was included, risk of all-cause mortality was 22.8% in the tight control vs 21.8% in the usual control group (adjusted HR, 1.15; 95% CI, 1.01-1.32; P=.04).

32. Conclusion Tight control of systolic BP among patients with diabetes and CAD was not associated with improved cardiovascular outcomes compared with usual control. Trial Registration clinicaltrials.gov Identifier: NCT00133692

33. Message and Comments すでに大血管障害のある糖尿病患者に限って観 察すると、血圧の管理をしないといけないが， 血圧の下げすぎはメリットがあまりないかもし れない。 ( 基本的に差がなければ下げてもよいと いう結論になるはずだが。また脳卒中ではやは り低めがよさそうだが。 ) もともと低めの血圧の対象については不明。 拡張期血圧についてはデータを出していないの で低めがよいかもしれない。また、腎症に対す る介入はまた異なる結果かもしれない。