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

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 目的：本研究的主要目的是确定水杨酸盐是否代表2型糖尿病管理的新药理学选择。本研究将分两个阶段进行，每个阶段均采用随机前瞻性设计。 参与者：一组患有2型糖尿病的志愿者将同意被随机分配到研究的第1阶段。 第二个队列将随机分配至研究第2阶段。 程序（方法）：第1阶段是一项为期14周的双盲安慰剂对照研究，旨在确定耐受性良好并表现出改善血糖的趋势的最佳剂量。 对照组中，参与者被分配到安慰剂或三种剂量的disalcid（每天3.0，3.4或4.0 gm）中的每一种。如果确定了最佳剂量，将进行研究的第2阶段，以确定 在实现血糖控制、耐受性和对炎症测量的影响方面的disalcid。第2阶段将包括一项为期26周的双盲安慰剂对照研究，其中将相同数量的受试者分配至安慰剂组或最佳剂量的disalcid组。将在安慰剂导入期观察每个阶段的所有受试者。 参与者将继续服用其他口服药物治疗2型糖尿病，就像他们在研究之前一样。

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.