TARGETING INFLAMMATION USING SALSALATE FOR TYPE 2 DIABETES STAGE II

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。 引言和基本原理 美国国立卫生研究院(NIH)的国家糖尿病、消化和肾脏疾病研究所(NIDDK)赞助了一项合作协议，以进行一项名为使用水杨酸盐治疗2型糖尿病的靶向炎症的临床治疗试验(TINSAL-T2D)。审判分两个阶段进行。第一阶段已于2008年7月24日完成并提交给dsmb。本方案描述了试验第二阶段的背景、设计和组织。 该方案由TINSAL-T2D研究小组的成员编写，由外部咨询委员会批准，并在开始招募之前由每个参与的临床中心的机构审查委员会(IRB)批准。 TINSAL-T2D研究小组的指导委员会由Joslin糖尿病中心、杜兰大学、乔治华盛顿大学生物统计中心和NIDDK项目办公室的研究人员组成。研究的程序手册(MOP)提供了详细的研究程序。 具体的目的和目的 这项研究的主要目的是确定水杨酸酯是否代表糖尿病治疗的一种新的药理学选择。这项研究分两个阶段进行。第一阶段的主要目标是选择一种既耐受性好又显示出血糖控制改善趋势的水杨酸盐剂量。研究第二阶段的主要目标是评估： 水杨酸盐对糖尿病患者血糖控制的影响； 2型糖尿病(T2D)患者对水杨酸盐的耐受性 水杨酸盐对炎症、代谢综合征和心脏风险的影响

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. Introduction and Rationale The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has sponsored a collaborative agreement to conduct a clinical treatment trial, entitled Targeting Inflammation Using Salsalate for Type 2 Diabetes (TINSAL-T2D). The trial is conducted in two stages. Stage I was completed and presented to the DSMB on July 24, 2008. This protocol describes the background, design and organization of Stage II of the trial. The protocol was written by the members of the TINSAL-T2D Study Group, approved by an External Advisory Board, and approved by the Institutional Review Boards (IRB's) of each participating clinical center prior to the initiation of recruitment. The Steering Committee for the TINSAL-T2D Study Group is composed of investigators at Joslin Diabetes Center, Tulane Univeristy, the George Washington University Biostatistics Center, and the NIDDK project office. Detailed study procedures are provided in the study's manual of procedures (MOP). Specific Aims and Objectives The primary objective of the study is to determine whether salicylates represent a new pharmacologial option for diabetes management. The study is conducted in two stages. The primary objective of the first stage was to select a dose of salsalate that was both well-tolerated and demonstrated a trend toward improvement in glycemic control. The primary objective of Stage II of the study is to evaluate: the effects of salsalate on glycemic control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk