PK OF SILYBIN-PHOSPHATIDYLCHOLINE COMPLEX (SILIPHOS) IN DIABETIC NEPHROPATHY

水飞蓟宾-磷脂酰胆碱复合物 (SILIPHOS) 在糖尿病肾病中的 PK

• 批准号: 7378222
• 负责人: PAOLO FANTI
• 金额: $ 1.07万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378222
• 关键词: PK; SILYBIN; PHOSPHATIDYLCHOLINE; COMPLEX; SILIPHOS

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. OBJECTIVE: To characterize the pharmacokinetics of Siliphos in individuals with type II diabetes mellitus with and without renal involvement following both single dose and sustained intake (one week) of Siliphos. RESEARCH PLAN and METHODS: Thirty-six subjects diagnosed with type II diabetes mellitus will be required. They will be divided in three groups based on severity of renal disease: 12 without evidence of renal disease, 12 with stage III chronic kidney disease and 12 with stage IV chronic kidney disease. Subjects will have 7 study visits (screening, pharmacokinetic inpatient visit 1, 2 outpatient visits (24 and 48 hours following the inpatient visit), pharmacokinetic inpatient visit 2, 2 outpatient visits (24 and 48 hours following the inpatient visit). The first inpatient visit will be to determine the single-dose pharmacokinetics in the Siliphos naive patient. The second will be to document steady state dynamics following one week on a regular dose of Siliphos at 160 mg po bid. Two to four weeks will elapse between the two tests. The pharmacokinetic test will include blood and urine collection during a 25 hour inpatient stay at the General Clinical Research Center (GCRC) at the Audie L. Murphy VA Hospital (ALMVAH) followed by two outpatient visits 24 and 48 hours after discharge. Blood and urine samples are also taken at the outpatient visits. CLINICAL RELEVANCE: Siliphos is a potent antioxidant that may prevent renal damage, reduce insulin resistance in diabetic patients and correct lipid abnormalities.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。目的：研究单剂量和持续服用（一周）Siliphos后，Siliphos在伴有和不伴有肾脏受累的2型糖尿病患者中的药代动力学特征。研究计划和方法：需要36名诊断为II型糖尿病的受试者。他们将根据肾脏疾病的严重程度分为三组：12人没有肾脏疾病的证据，12人患有III期慢性肾脏疾病，12人患有IV期慢性肾脏疾病。受试者将进行7次研究访视(筛查、药代动力学住院访视1次、门诊访视2次（住院访视后24和48小时）、药代动力学住院访视2次、门诊访视2次（住院访视后24和48小时）。第一次住院访问将是确定Siliphos患者的单剂量药代动力学。第二项研究将记录在常规剂量160毫克/次硅氧烷注射一周后的稳态动力学。两次测试之间相隔两到四周。药代动力学测试将包括在Audie L. Murphy VA医院（ALMVAH）的普通临床研究中心（GCRC）住院25小时期间收集血液和尿液，然后在出院后24小时和48小时进行两次门诊。在门诊就诊时也要采集血液和尿液样本。临床意义：Siliphos是一种有效的抗氧化剂，可以预防肾脏损害，降低糖尿病患者的胰岛素抵抗，纠正脂质异常。