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

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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.