TARGETING INFLAMMATION USING SALSALATE FOR TYPE 2 DIABETES (TINSAL-T2D)

使用水杨酸靶向炎症治疗 2 型糖尿病 (TINSAL-T2D)

• 批准号: 7716891
• 负责人: Steven P. Braithwaite
• 金额: $ 0.21万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716891
• 关键词: Computer Retrieval of Information on Scientific Projects Database; Consent; Dose; Double-Blind Method; Exhibits; Funding; Grant; Inflammation; Institution; Measures; Methods; Non-Insulin-Dependent Diabetes Mellitus; Numbers; Oral; Participant; Personal Satisfaction; Phase; Placebos; Procedures; Purpose; Randomized; Research; Research Personnel; Resources; Running; Sodium Salicylate; Source; Staging; United States National Institutes of Health; cohort; day; design; diabetes management; glycemic control; placebo controlled study; prospective; salicylate; salicylsalicylic acid; trend; volunteer

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. Purpose: The primary objective of the study is to determine whether salicylates represent a new pharmacological option for type 2 diabetes management. The study will be conducted in two stages each having randomized prospective design. Participants: A cohort of volunteers having type 2 diabetes will consent to be randomized for Stage 1 of the study. A second cohort will be randomized for Stage 2 of the study. Procedures (methods): Stage 1 will be a double-blind placebo-controlled study of 14 wk duration, intended to determine the optimal dose of disalcid that is well tolerated and exhibits a trend toward improvement of glycemic control, in which participants are assigned in equal numbers to placebo or each of three doses of disalcid (3.0, 3.4, or 4.0 gm per day). If an optimal dose is defined, Stage 2 of the study will be conducted to determine efficacy of disalcid in achieving glycemic control, tolerability, and effect upon measures of inflammation. Stage 2 will consist of a 26 wk double blind-placebo controlled study in which participants are assigned in equal numbers to placebo or to the optimal dose of disalcid. All participants in each Stage will be observed during a placebo run-in phase. Participants will continue taking other oral agens for type 2 diabetes exacly as they had prior to the study.

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：本研究的主要目的是确定水杨酸酯是否代表了治疗2型糖尿病的一种新的药理学选择。这项研究将分两个阶段进行，每个阶段都有随机前瞻性设计。 参与者：一组患有2型糖尿病的志愿者将同意在研究的第一阶段随机进行。第二个队列将在研究的第二阶段随机进行。 程序(方法)：第一阶段将是一项为期14周的双盲安慰剂对照研究，旨在确定耐受性良好并显示出血糖改善趋势的最佳脱碱剂剂量。 对照组，参与者被分成等量的安慰剂或三种剂量(每天3.0、3.4或4.0克)中的每一种。如果确定了最佳剂量，将进行研究的第二阶段，以确定 在实现血糖控制、耐受性和对炎症措施的影响方面的消碱作用。第二阶段将包括一项为期26周的双盲-安慰剂对照研究，参与者被分配到同等数量的安慰剂或最佳剂量的脱盐剂。每个阶段的所有参与者都将在安慰剂磨合阶段接受观察。参与者将继续服用其他治疗2型糖尿病的口服抗原，就像他们在研究之前一样。