N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

This is an interventional treatment trial for Diabetic Nephropathies focused on measuring Diabetic Nephropathies, Proteinuria, Renal Insufficiency, Chronic, Monocytes, Oxidative stress, Inflammation, Antioxidants, Glutathione, Silymarin, Acetylcysteine, Dietary Supplements, Complementary Therapies Read More

Inclusion Criteria:

• Males or females, age 18-70 years old.
• Type 2 diabetes mellitus

• Diabetic nephropathy, as defined by:

  • estimated GFR between 60 and 15 ml/min,
  • presence of proteinuria.
• Current medical treatment with low dose aspirin
• Treatment of hypertension with (but not limited to) one diuretic, one beta- blocker and one medication from the classes ARBs or ACE inhibitors.
• Treatment of hyperglycemia with (but not limited to) glipizide and the medication class insulin.
• Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins.

Exclusion Criteria:

• Type 1 diabetes mellitus.
• Glycosylated hemoglobin (HbA1C) > 10%
• >20% variation in estimated GFR, during last 6 months
• SBP >170 mmHg or DBP >100 mmHg on medications
• Other secondary forms of hypertension (endocrine, renovascular)

• History of intolerance to:

  • Both ACE-I and ARBs;
  • The investigational supplements;
  • Iodinated radiologic contrast material.
• Known non diabetic renal disease, or history of solid organ transplantation.
• Hepatitis virus or Human Immunodeficiency virus infections

• Use of one of the following medications within 2 months prior to enrollment in the study:

  • Metformin.
  • Thiazolidinediones (pioglitazone or rosiglitazone);
  • Prescription-grade vitamin E, vitamin C, systemic steroids, and/or non-steroidal anti-inflammatory agents;
  • Over-the-counter vitamin E, vitamin C, and/or non-steroidal anti-inflammatory agents.
  • Over-the-counter antioxidants supplements including: Lipoic acid, Coenzyme Q10, N-acetyl-cysteine (NAC), Glutathione (GSH), Chromium, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Milk thistle extract (silymarin), Green-tea preparations, Pomegranate extracts, Grape extracts, and Prickly pear extract.
• Active coronary artery disease or cerebral vascular disease within 3 months prior to signing the informed consent.
• Hepatic dysfunction as defined by abnormal total bilirubin or liver enzymes (ALT, AST) >2 times upper limit of normal range.
• Active malignancy.
• History of drug or alcohol dependency.
• Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol
• Unwillingness to practice birth control throughout the study.
• Participation to another clinical study within 1 month prior to signing the informed consent form.
• Planned move to outside the study area, surgery or radiographic studies utilizing iodine-based contrast material within the next one year