NIDDM PRIMARY PREVENTION TRIAL (DPT 2)

NIDDM 一级预防试验 (DPT 2)

• 批准号: 6517331
• 负责人: BARRY J. GOLDSTEIN
• 金额: $ 27.12万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-08-15 至 2003-05-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6517331
• 关键词: African American; Hispanic Americans; Native Americans; caucasian American; clinical trials; cooperative study; diabetes mellitus therapy; disease /disorder prevention /control; gestational diabetes mellitus; glucose tolerance test; human subject; human therapy evaluation; insulin sensitivity /resistance; metabolism disorder diagnosis; noninsulin dependent diabetes mellitus; prediabetic state

The objective of this multicenter clinical trial is to develop interventions to prevent the development of NIDDM in people with a history of gestational diabetes (GDM) and impaired glucose tolerance (IGT) (Cohort I primary prevention) and the worsening of glucose tolerance in people with newly diagnosed NIDDM with an FPG less than 140 mg/dl (Cohort II, secondary prevention). The central hypothesis of this application is that improvement of insulin resistance will delay the onset of NIDDM in individuals at risk. Therefore, we propose a five year randomized non-pharmacological and pharmacological factorial treatment design aimed to improve insulin resistance: Stratification will assure an overall trial representation of Black (0.4), Hispanic (0.2), Native American (0.2), GDM (0.2) and other races including Caucasian (1.0) Power calculations indicate that 20 centers contributing with 200 patients each will be necessary to fulfill the goal of the study. We will recruit the study subjects from among the Thomas Jefferson University employees. From a preliminary survey of the 7,294 full-time employees with a response rate of 58% revealed that 52% of the employees are at risk for NIDDM and that 76% have indicated interest in a NIDDM prevention trial, if available. It is hoped that the screening treatment follow-up and outcome measures methods will be translated to the society at large. To this end, it is important that both community and work-site models be developed.

这项多中心临床试验的目的是发展 采取干预措施，以防止患有A的NIDDM发展 妊娠糖尿病病史（GDM）和葡萄糖耐量受损 （IGT）（队列I初级预防）和葡萄糖的恶化 FPG小于140的新诊断为NIDDM的人的容忍度 mg/dl（队列II，二级预防）。 中心假设 应用是胰岛素抵抗的改善将延迟 NIDDM发作的个人处于危险之中。 因此，我们建议五年 随机非药理学和药理学阶乘治疗 设计旨在提高胰岛素抵抗： 分层将确保黑色的整体试验表示 （0.4），西班牙裔（0.2），美国原住民（0.2），GDM（0.2）和其他种族 包括高加索人（1.0）功率计算表明20个中心 为实现目标，每个患者都必须为200名患者做出贡献 研究。 我们将从托马斯·杰斐逊（Thomas Jefferson）中招募研究对象 大学员工。 从对7,294个全日制的初步调查 响应率为58％的员工表明52％的员工 有NIDDM的风险，有76％的人表示对NIDDM的兴趣 预防试验，如果有的话。 希望筛查治疗 后续措施和结果措施方法将转化为社会 整个。 为此，重要的是社区和工作地点 开发模型。