Chiasson J L, Gomis R, Hanefeld M, Josse R G, Karasik A, Laakso M
Centre Hospitalier de L'Université de Montréal, Department of Medicine, University of Montreal, Quebec, Canada.
Diabetes Care. 1998 Oct;21(10):1720-5. doi: 10.2337/diacare.21.10.1720.
To describe the rationale and design, and to discuss the preliminary screening data, of the Study to Prevent NIDDM (STOP-NIDDM Trial), an international study on the efficacy of the alpha-glucosidase inhibitor acarbose in preventing or delaying the development of type 2 diabetes in a population with impaired glucose tolerance (IGT).
A total of 1,418 subjects diagnosed with IGT according to the World Health Organization's criteria and having a fasting plasma glucose concentration > or =5.6 mmol/L were randomized in a double-blind fashion to receive either acarbose (100 mg t.i.d.) or placebo for a predictive median follow-up period of 3.9 years. The primary outcome is the development of type 2 diabetes diagnosed using a 75-g oral glucose tolerance test according to the new criteria. The secondary outcomes are changes in blood pressure, lipid profile, insulin sensitivity, cardiovascular events, and morphometric profile.
Screening was performed in a high-risk population. As of 1 March 1997, 4,424 subjects had been screened, and data were available for 3,919 (88.5%) subjects. Of these subjects, 1,200 (30.6%) had glucose intolerance. Of the subjects with glucose intolerance, 521 (13.3%) had previously undetected type 2 diabetes, and 679 (17.3%) had IGT. Of the IGT population, 412 (60.7%) subjects were eligible for the study This population had the following characteristics: the mean age was 54.8 years, 52% of the subjects were female, 53% had more than one risk factor for type 2 diabetes, >90% had a family history of diabetes, 78.2% had a BMI > or =27 kg/m2, 47.5% had high blood pressure, 51.2% had dyslipidemia, and 22.8% of the women had a history of gestational diabetes.
Screening of a high-risk population yields one eligible subject per every 10 volunteers screened. This study should definitely answer the question of whether acarbose can prevent or delay the progression of IGT to type 2 diabetes mellitus.
描述预防非胰岛素依赖型糖尿病研究（STOP - NIDDM试验）的基本原理、设计并讨论初步筛查数据。该试验是一项关于α - 葡萄糖苷酶抑制剂阿卡波糖在糖耐量受损（IGT）人群中预防或延缓2型糖尿病发生疗效的国际研究。
根据世界卫生组织标准诊断为IGT且空腹血糖浓度≥5.6 mmol/L的1418名受试者，以双盲方式随机分组，分别接受阿卡波糖（100 mg，每日三次）或安慰剂治疗，预计中位随访期为3.9年。主要结局是根据新标准通过75 g口服葡萄糖耐量试验诊断的2型糖尿病的发生。次要结局包括血压、血脂谱、胰岛素敏感性、心血管事件和形态学指标的变化。
在高危人群中进行了筛查。截至1997年3月1日，已筛查4424名受试者，3919名（88.5%）受试者有可用数据。在这些受试者中，1200名（30.6%）有糖耐量异常。在糖耐量异常的受试者中，521名（13.3%）之前未被检测出患有2型糖尿病，679名（17.3%）患有IGT。在IGT人群中，412名（60.7%）受试者符合研究条件。该人群具有以下特征：平均年龄54.8岁，52%为女性，53%有一个以上2型糖尿病危险因素，>90%有糖尿病家族史，78.2%体重指数（BMI）≥27 kg/m²，47.5%患有高血压，51.2%患有血脂异常，22.8%的女性有妊娠期糖尿病史。
对高危人群进行筛查，每10名筛查志愿者中有1名符合条件的受试者。本研究肯定能回答阿卡波糖是否能预防或延缓IGT进展为2型糖尿病这一问题。
