Evaluation of effect of dietary education for prevention of Type 2 diabetes

目的：在一项随机对照试验中评估饮食教育对日本男性工人高危患者预防2型糖尿病的有效性。研究设计与方法：本研究是一项前瞻性、随机、对照临床试验，对新饮食教育计划或传统饮食教育的患者进行两种水平的饮食教育（DE）。新饮食教育的目标是达到并维持最佳血糖水平，调整营养摄入和生活方式，以适当预防，解决个人营养需求，在尊重个人意愿和意愿的同时考虑个人和文化偏好。并提倡健康的饮食模式。研究假设，新的DE可能会降低10%的2小时空腹血糖（2小时FPG）与1和6个月DE在1年内。数据在研究开始时和1年后收集。研究对象是141名年龄在35岁以上的日本大都市男性工人，他们被诊断为2型糖尿病的高危人群。根据显著性水平为5%，功率为90%，应答率为90%左右的信息确定样本量。主要终点是2小时FPG降低10%，饮食摄入量的改善是次要终点。采用协方差分析对数据进行分析。治疗意向采用logistic回归分析进行检验。结果：分析对象为170人（91.9%），其中新DE 88人，常规DE 82人。在1年时，新DE导致血糖控制的显著改善，如2小时FPG（<0.001）和饮食摄入量（<0.001）。至于ITT，没有证据表明2小时FPG减少10%的人数。结论：由营养师使用FFQ提供的新DE可显著改善2型糖尿病高危患者的健康状况。

OBJECTIVE: To assess in a randomized controlled trial the effectiveness of dietary education to prevent Type 2 diabetes for a high risk patients of Japanese male workers.RESEARCH DESIGN AND METHODS: This study was a prospective, randomized,controlled clinical trial of two levels of dietary education (DE) in persons with new DE program or conventional DE. The goals of the new DE were to attain and maintain optimal blood glucose levels, to modify nutrient intake and lifestyle as appropriate for prevention, to address individual nutritional needs, taking into consideration personal and cultural preferences as while respecting the individual wishes and willingness to change, and to promote healthy food intake pattern. The study hypothesis was that the new DE might reduce 10% of 2-h fasting plasma glucose (2-h FPG) with a 1 and 6 month DE during 1 year.Data were collected at entry to the study and 1 year after. Subjects were 141 male workers aged over 35 years in a metropolitan area of JAPAN who diagnosed as a high risk group of Type 2diabetes. The sample size was determined based on the information with significant level of 5%, power of 90%, and response rate around 90%. Primary endpoint was 10% reduction of 2-h FPG and improvements of dietary intakes were secondary outcome measures. The data was analyzed using analysis of covariance. Intention to treat was examined using logistic regression analysis.RESULTS: The subjects for the analysis were 170(91.9%) individuals, 88 for new DE, 82 for conventional DE. At 1 year, the new DE resulted in significance improvements in blood glucose control as indicated by 2-h FPG (<0.001) and dietary intakes (<0.001). As for ITT, no evidence was obtained for number of persons with 10% reduction of 2-h FPG.CONCLUSIONS: The new DE provided by dietitians using FFQ resulted in significant improvements and beneficial to high risk persons with Type 2 diabetes.