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

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。 目的：研究单剂量和持续服用(一周)Siliphos在伴有和不伴有肾脏损害的II型糖尿病患者中的药代动力学特征。 研究计划和方法：研究对象为36名被诊断为II型糖尿病的受试者。根据肾脏疾病的严重程度，这些患者将被分为三组：12例没有肾脏疾病的证据，12例为第三阶段慢性肾脏疾病，12例为第四阶段慢性肾脏疾病。受试者将有7次研究就诊(筛查、药代动力学住院1次、2次门诊(住院后24小时和48小时)、2次药代动力学住院2次、2次门诊(住院24小时和48小时))。第一次住院探视将确定Siliphos幼稚患者的单剂药代动力学。第二项是记录常规剂量的Siliphos以160 mg po bid服药一周后的稳态动力学。两次测试之间将相隔两到四周。药代动力学测试将包括在奥迪·L·墨菲VA医院(ALMVAH)的综合临床研究中心(GCRC)住院25小时期间采集血液和尿液，然后在出院24小时和48小时后进行两次门诊。在门诊时也会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，纠正血脂异常。

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.