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 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。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，我们将尝试预防 200 名糖耐量受损受试者发生 NIDDM。 研究计划：糖尿病预防试验 (DPP) 是一项大型多中心研究，测试了以下假设：使用强化生活方式改变或药物（二甲双胍）可以延缓或预防高危人群 2 型糖尿病的发病由于葡萄糖耐量受损（IGT）而导致其发育。糖耐量受损代表血糖异常的较轻阶段，通常先于 2 型糖尿病发生。 方法：DPP 试验的主要研究问题是确定两种干预措施（强化生活方式或二甲双胍）相对于控制干预措施（标准生活方式改变）在延迟或预防 2 型糖尿病发病方面的安全性和有效性。次要终点包括脂质、脂蛋白、踝/臂比、尿白蛋白和颈动脉壁厚度的变化。受试者将通过多种方法获得，包括： (a) 通过广播和电视广告进行社区广告； (b) 市中心大学中心的选择性筛选基地； (c) 来自圣安东尼奥心脏研究的受试者。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）的受试者将参加平行二级预防试验，以预防空腹高血糖的发生。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的评估。