There is considerable evidence that increased blood glucose results in the generation of reactive oxygen species, ultimately leading to increased oxidative stress in a variety of tissues. This may lead to the activation of stress-sensitive intracellular signaling pathways, causing cellular damage and late complications of diabetes including renal injury. Although the investigators understanding of how hyperglycemia-induced oxidative stress ultimately leads to tissue damage has advanced considerably in recent years, effective therapeutic strategies to prevent or delay the development of this damage remain limited. The flavonoid complex silymarin, an extract from the milk thistle, and its major pharmacological active component silibinin are free radical scavengers and potent membrane stabilizers by preventing lipid peroxidation. Furthermore, during early stages of diabetes, flavonoids minimize oxidative stress, and inflammation which represent important factors in the development of diabetic nephropathy. In this study the investigators plan to evaluate the renoprotective effect of milk thistle extract on type II diabetic patients with kidney disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
140 mg placebo tablets, 3 times per day for 3 months
1 tablet equal to 140mg silymarin administered 3 times a day for 3 months
Motahari Clinic
Shiraz, Fars, Iran
Change from baseline in urinary albumin-creatinine ratio
Time frame: 3 month
Change from baseline in urinary TNF-α
Time frame: 3 month
Change from baseline in urinary TGF-β
Time frame: 3 month
Change from baseline in fasting plasma glucose
Time frame: 3 month
Change from baseline in blood lipid profile
Time frame: 3 month
Change from baseline in hemoglobin A1C
Time frame: 3 month
Change from baseline in urinary MDA
Time frame: 3 month
Change from baseline in serum TNF-α
Time frame: 3 month
Change from baseline in serum TGF-β
Time frame: 3 month
Change from baseline in serum MDA
Time frame: 3 month
Change from baseline in estimated GFR
Time frame: 3 month
Change from baseline in serum creatinine
Time frame: 3 month
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