NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM) PRIMARY PREVENTION TRIAL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目的：作为多中心资助(DK-93-07，非胰岛素依赖型糖尿病一级预防试验)的一部分，我们将尝试在200名糖耐量受损的受试者中预防NIDDM的发生。 研究计划：糖尿病预防试验(DPP)是一项大型的多中心研究，它测试了一项假设，即在糖耐量受损(IGT)的高危人群中，密集改变生活方式或药物(二甲双胍)的使用可以延缓或防止2型糖尿病的发生。糖耐量受损代表血糖异常的较轻阶段，通常是2型糖尿病的先兆。 方法：DPP试验的主要研究问题是确定两种干预措施(密集生活方式或二甲双胍)相对于对照干预措施(标准生活方式改变)在延缓或预防2型糖尿病发病方面的安全性和有效性。次要终点包括血脂、脂蛋白、踝臂比、尿白蛋白和颈动脉壁厚度的变化。受试者将通过几种方法获得，包括：(A)通过广播和电视广告进行社区广告；(B)从大学市中心的选择性筛选基地；以及(C)圣安东尼奥心脏研究的受试者。被确认患有新发现的糖尿病但空腹血糖正常(2小时血糖=200毫克/分升，但空腹血糖为140毫克/分升)的受试者将进入平行的二级预防试验，以防止空腹高血糖的发展。除了一级预防试验中受试者的终点外，这些受试者还将接受糖尿病神经病变和视网膜病变的评估。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: As part of a multi-center grant (DK-93-07, non-insulin dependent diabetes mellitus primary prevention trial), we will attempt to prevent the development of NIDDM in 200 subjects with impaired glucose tolerance. RESEARCH PLAN: The Diabetes Prevention Trial (DPP) is a large multi-center study that tested the hypothesis that the use of intensive lifestyle modification or medications (metformin) could delay or prevent the onset of type 2 diabetes in persons who are at high risk for its development by virtue of having impaired glucose tolerance (IGT). Impaired glucose tolerance represents a less severe stage of blood glucose abnormalities and often precedes type 2 diabetes. METHODS: The primary research question for the DPP Trial is to determine the safety and efficacy of two interventions (intensive lifestyle or metformin) relative to a control intervention (standard lifestyle modifications) in delaying or preventing the onset of type 2 diabetes. Secondary endpoints include changes in lipids, lipoproteins, ankle/arm ratio, urinary albumin, and carotid wall thickness. Subjects will be obtained by several methods including: (a) community advertising through radio and television advertisements; (b) selective screening base from the University Center Downtown; and (c) subjects from the San Antonio Heart Study. Subjects identified with newly discovered diabetes but with normal fasting glycemia (2-hr glucose = 200 mg/dl, but fasting glucose 140 mg/dl) will be entered into a parallel secondary prevention trial to prevent the development of fasting hyperglycemia. In addition to the endpoints for the subjects in the primary prevention trial, these subjects will have assessment for diabetic neuropathy and retinopathy.