PRIMARY PREVENTION TRIAL--DATA COORDINATING CENTER

说明(直接从应用程序中合并) 乔治华盛顿大学生物统计中心建议 与美国国家糖尿病研究所达成合作协议 以及消化和肾脏疾病(NIDDK)作为数据 建议的多中心临床试验的协调中心(DCC) 非胰岛素依赖型糖尿病的一级预防 (NIDDM)。肥胖和不活动已被确定为严重的 在糖耐量异常的病因中的因素和强烈 与葡萄糖不耐受风险增加有关。我们建议 确定强化生活方式干预的安全性和有效性 或预防性使用口服降糖药对糖尿病发病率的影响 NIDDM高危患者(肥胖、少数民族、NIDDM家族史、 妊娠期糖尿病病史)处于血糖受损状态 公差(IGT)。 一年规划阶段的目标是制定一项议定书， 操作手册和数据收集表格将在五年内实施 一年的全面临床试验。这项试验需要大规模的 4,000例确诊高危患者的筛查和随机选择 在20个临床中心进行为期一年的IGT评估。符合条件的病人 会被随机分成“常规”饮食咨询或 对照组(强化生活方式干预或口服药 降血糖药)。随机化的患者将至少接受跟踪调查 为期四年，每季度进行一次后续访问。从一种状态转换 IGT对显性NIDDM的比例将通过每半年2小时的口服来确定 75g葡萄糖负荷后的葡萄糖耐量试验(OGTTS)确认 由一个中心实验室完成。协变量和次要结果包括 颈动脉超声成像、心电图、血脂、白蛋白 排泄率、肥胖、胰岛素敏感性、血红蛋白A1c和 眼底照片。 DCC的具体目标是提供集中支持和 生物统计会诊在患者管理中的发展 协议、操作手册、数据收集表格和随机化 程序；包括数据的数据处理系统的实施 质量评估；协议性能的中期分析，患者 安全性和治疗效果；以及出版该 结果与临床研究人员合作。

DESCRIPTION (Directly incorporated from the application) The Biostatistics Center of The George Washington University proposes to work in cooperative agreement with the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) to serve as the Data Coordinating Center (DCC) for a proposed multi-center clinical trial of the primary prevention of non-insulin dependent diabetes mellitus (NIDDM). Adiposity and inactivity have been established as critical factors in the etiology of glucose intolerance and are strongly associated with increased risk of glucose intolerance. We propose to determine the safety and efficacy of an intensive lifestyle intervention or prophylactic use of an oral hypoglycemic agent on the incidence of NIDDM among high risk patients (obese, minority, family history of NIDDM, history of gestational diabetes mellitus) in a state of impaired glucose tolerance (IGT). The objective of the one year planning phase is to develop a protocol, operations manual and data collection forms to be implemented in a five year full-scale clinical trial. The trial will require large-scale screening and randomization of 4,000 high risk patients with a diagnosis of IGT over a one year period in 20 clinical centers. Eligible patients will be randomized to "conventional" dietary counseling or one of the comparison groups (intensive lifestyle intervention or an oral hypoglycemic agent). Randomized patients will be followed for a minimum of four years with quarterly follow-up visits. Conversion from a state of IGT to overt NIDDM will be determined by semi-annual 2-hour oral glucose tolerance tests (OGTTs) following a 75 g glucose load confirmed by a central laboratory. Covariates and secondary outcomes include carotid ultrasound imaging, electrocardiograms, serum lipids, albumin excretion rate, adiposity, insulin sensitivity, hemoglobin A1c, and fundus photographs. The specific aims of the DCC are to provide centralized support and biostatistical consultation in the development of the patient management protocols, operations manual, data collection forms and randomization procedures; implementation of a data processing system including data quality assessment; interim analysis of protocol performance, patient safety and treatment efficacy; and final analysis for publication of the results in collaboration with the clinical investigators.