PRIMARY PREVENTION PROGRAM -DATA COORDINATING CENTER

描述（直接从申请中合并） 乔治华盛顿大学生物统计中心提议 与美国国立糖尿病研究所达成合作协议 和消化及肾脏疾病 (NIDDK) 作为数据 协调中心（DCC）拟定的多中心临床试验 非胰岛素依赖型糖尿病的一级预防 （NIDDM）。 肥胖和缺乏运动已被确定为关键 葡萄糖不耐症的病因学因素和强烈 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血糖药对发生率的影响 NIDDM 高危患者（肥胖、少数民族、NIDDM 家族史、 妊娠糖尿病史）处于葡萄糖受损状态 耐受性（IGT）。 一年规划阶段的目标是制定一项协议， 将在五个阶段实施操作手册和数据收集表格 年全面临床试验。 该试验需要大规模 对 4,000 名确诊的高危患者进行筛查和随机分组 20 个临床中心在一年内对 IGT 进行了研究。 符合资格的患者 将被随机分配接受“传统”饮食咨询或其中一项 对照组（强化生活方式干预或口服 降血糖药）。 随机患者将被跟踪至少 为期四年，每季度进行一次随访。 从状态转换 IGT 与显性 NIDDM 的关系将通过每半年 2 小时的口服测试来确定 确认 75 克葡萄糖负荷后的葡萄糖耐量测试 (OGTT) 由一个中心实验室。 协变量和次要结果包括 颈动脉超声检查、心电图、血脂、白蛋白 排泄率、肥胖、胰岛素敏感性、糖化血红蛋白和 眼底照片。 DCC 的具体目标是提供集中支持和 患者管理发展中的生物统计咨询 方案、操作手册、数据收集表格和随机化 程序；数据处理系统的实现，包括数据 质量评估；方案性能的中期分析，患者 安全性和治疗效果；以及发布的最终分析 与临床研究人员合作得出的结果。

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.