PRIMARY PREVENTION PROGRAM -DATA COORDINATING CENTER

描述（直接从申请中并入） 乔治华盛顿大学的生物统计中心建议， 与美国国立糖尿病研究所合作 以及消化和肾脏疾病（NIDDK）作为数据 协调中心（DCC），用于拟定的多中心临床试验， 非胰岛素依赖型糖尿病一级预防 （NIDDM）。 肥胖和不活动已被确定为关键 葡萄糖耐受不良的病因因素， 与葡萄糖耐受不良风险增加有关。 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剂对 NIDDM高危患者（肥胖、少数民族、NIDDM家族史， 妊娠期糖尿病史）处于血糖受损状态 耐受性（IGT）。 为期一年的规划阶段的目标是制定一项协议， 业务手册和数据收集表格将在五个 一年的全面临床试验。 试验将需要大规模的 对4,000名诊断为高风险患者进行筛查和随机分组， 在20个临床中心进行为期一年的IGT研究。 合格患者 将被随机分配到“传统”饮食咨询或 对照组（强化生活方式干预或口服 降血糖剂）。 随机化患者将至少随访 每四年进行一次季度随访 从一个国家转换 IGT至显性NIDDM的比例将通过每半年2小时口服 75 g葡萄糖负荷后的葡萄糖耐量试验（OGTT）证实 一个中心实验室。 协变量和次要结局包括 颈动脉超声显像，心电图，血脂，白蛋白 排泄率、肥胖、胰岛素敏感性、血红蛋白A1 c，以及 眼底照片。 发展协调委员会的具体目标是提供集中支助， 生物统计咨询在病人管理发展中的作用 方案、操作手册、数据收集表和随机化 数据处理系统的实现 质量评估;方案性能中期分析，患者 安全性和治疗有效性;以及最终分析， 结果与临床研究者合作。

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.