TARGETING INFLAMMATION USING SALSALATE FOR TYPE 2 DIABETES STAGE II

使用水杨酸针对炎症治疗 2 型糖尿病 II 期

• 批准号: 7952021
• 负责人: Vanita Aroda
• 金额: $ 1.9万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952021
• 关键词: Agreement; Biometry; Cardiac; Clinical; Clinical Research; Clinical Treatment; Computer Retrieval of Information on Scientific Projects Database; Diabetes Mellitus; Dose; Funding; Grant; Inflammation; Institution; Manuals; Measures; Metabolic syndrome; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Patients; Procedures; Protocols documentation; Research; Research Ethics Committees; Research Personnel; Resources; Risk; Source; Staging; United States National Institutes of Health; Universities; Washington; Writing; design; diabetes management; glycemic control; member; salicylate; salicylsalicylic acid; treatment trial; trend

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

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 简介和基本原理 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，以开展一项名为“使用 Salsalate 治疗 2 型糖尿病的靶向炎症”(TINSAL-T2D) 的临床治疗试验。 审判分两个阶段进行。 第一阶段已完成并于 2008 年 7 月 24 日提交给 DSMB。该协议描述了第二阶段试验的背景、设计和组织。 该方案由 TINS​​AL-T2D 研究组成员编写，经外部顾问委员会批准，并在招募开始前得到每个参与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。研究程序手册 (MOP) 中提供了详细的研究程序。 具体目的和目标 该研究的主要目的是确定水杨酸盐是否代表糖尿病管理的新药理学选择。 该研究分两个阶段进行。 第一阶段的主要目标是选择一种耐受性良好且有改善血糖控制趋势的水杨酸剂量。 研究第二阶段的主要目标是评估： 水杨酸对糖尿病血糖控制的影响； 2 型糖尿病 (T2D) 患者使用双水杨酯的耐受性；和 水杨酸对炎症、代谢综合征和心脏病风险指标的影响