TARGETING INFLAMMATION USING SALSALATE FOR TYPE 2 DM

使用水杨酸针对炎症治疗 2 型糖尿病

• 批准号: 8166869
• 负责人: Robert Roy Henry
• 金额: $ 0.47万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166869
• 关键词: Behavior Therapy; C-Peptide; Cholesterol; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Dose; Evaluable Disease; Funding; Glycosylated hemoglobin A; Grant; High Density Lipoprotein Cholesterol; High Density Lipoproteins; Homeostasis; Hyperglycemia; Inflammation; Institution; Insulin; LDL Cholesterol Lipoproteins; Lipids; Measurement; Metformin; Modeling; Non obese; Obesity; Participant; Patients; Pharmaceutical Preparations; Placebos; Population; Randomized; Research; Research Personnel; Resources; Safety; Source; Time; Triglycerides; United States National Institutes of Health; discontinuation trial; fasting glucose; indexing; insulin secretagogues; insulin sensitivity; primary outcome; response; salicylsalicylic acid; secondary outcome; 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. The primary outcome for the TINSAL-T2D study is change in HbA1c level from baseline to week 26 in the intent-to-treat (ITT) population with last observation carried forward. The ITT population is defined as any patient who has at least one post-baseline measurement of HbA1c and has taken at least one dose of the randomized study drug. Important secondary outcomes for both the ITT and evaluable populations include: Change from baseline to either 26 weeks or last HbA1c measurement prior to rescue therapy Trends in HbA1c over time Change from baseline and trends in fasting glucose over time Response rates for reduction in fasting glucose of =20 mg/dl, a reduction in HbA1c of =0.5%, and a reduction in HbA1c of =0.8% Change in lipids (low-density lipoprotein cholesterol [LDL-C], non-high-density lipoprotein cholesterol [non-HDL-C], triglycerides [TG], total cholesterol [TC], high-density lipoprotein cholesterol [HDL C], TC/HDL-C ratio, and LDL-C/HDL-C ratio) Change in insulin sensitivity (insulin, C-peptide, homeostasis model [HOMA] index) Response rates for exceeding hyperglycemic targets between active and placebo treated groups Need for rescue therapy Need for discontinuation of study medication Response rates in patients initially treated with lifestyle modification, insulin secretagogue, metformin or combination therapy Response rates for a reduction in HbA1c for obese vs non-obese participants Safety and tolerability of salsalate compared to placebo

这个子项目是许多研究子项目中的一个 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， 因此可以在其他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。 TINSAL-T2 D研究的主要结局是意向治疗（ITT）人群中HbA 1c水平自基线至第26周的变化，末次观察值结转。ITT人群定义为至少有一次基线后HbA 1c测量值且至少接受过一次随机化研究药物给药的任何患者。ITT和可评价人群的重要次要结局包括： 从基线至第26周或补救治疗前末次HbA 1c测量值的变化 HbA 1c随时间的变化趋势 空腹血糖随时间较基线的变化和趋势 空腹血糖降低≥ 20 mg/dl、HbA 1c降低≥ 0.5%和HbA 1c降低≥ 0.8%的应答率 脂质变化（低密度脂蛋白胆固醇[LDL-C]、非高密度脂蛋白胆固醇[非HDL-C]、甘油三酯[TG]、总胆固醇[TC]、高密度脂蛋白胆固醇[HDL-C]、TC/HDL-C比值和LDL-C/HDL-C比值） 胰岛素敏感性变化（胰岛素、C肽、稳态模型[HOMA]指数） 活性药物治疗组和安慰剂治疗组之间超过高血糖目标的应答率 需要补救治疗 需要停用研究药物 最初接受生活方式改变、胰岛素促分泌剂、二甲双胍或联合治疗的患者的缓解率 肥胖与非肥胖受试者HbA 1c降低的应答率 双水杨酯与安慰剂相比的安全性和耐受性