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

非胰岛素依赖型糖尿病 (NIDDM) 一级预防试验

• 批准号: 7378154
• 负责人: STEVEN M. HAFFNER
• 金额: $ 7.45万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378154
• 关键词: NON; INSULIN; DEPENDENT; DIABETES; MELLITUS

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。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例糖耐量受损受试者中预防NIDDM的发生。 研究报告：糖尿病预防试验（DPP）是一项大型多中心研究，旨在验证以下假设：使用强化的生活方式改变或药物（二甲双胍）可以延迟或预防2型糖尿病的发生，这些人由于葡萄糖耐量受损（IGT）而处于其发展的高风险中。葡萄糖耐量受损代表血糖异常的不太严重的阶段，并且通常先于2型糖尿病。 方法：DPP试验的主要研究问题是确定两种干预（强化生活方式或二甲双胍）相对于对照干预（标准生活方式改变）在延迟或预防2型糖尿病发作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。将通过几种方法获得受试者，包括：（a）通过广播和电视广告进行社区宣传;（B）从市中心大学中心进行选择性筛选;（c）从圣安东尼奥心脏研究中获得受试者。新发现糖尿病但空腹血糖正常（2小时血糖= 200 mg/dl，但空腹血糖140 mg/dl）的受试者将进入平行二级预防试验，以预防空腹高血糖症的发生。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评估。