N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is done to find out whether the combined use of the nutritional supplements N-acetylcysteine and Siliphos (milk thistle extract) corrects the shedding of urine protein and oxidative damage (damage to cells and organs often compared to fast aging) in patients with Type 2 Diabetes Mellitus (T2DM) and diabetic kidney disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Acetylcysteine; N-monoacetylcystine; Silybin; Silymarin

Criteria

Inclusion Criteria:

• Males or females age 18-76 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 Angiotensin Receptor Blockers (ARBs) or Angiotensin Converting Enzyme inhibitors (ACE-I)

• 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

• Systolic Blood Pressure >170 mmHg or Diastolic Blood Pressure >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)

• Phenytoin

• Warfarin

• 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

• 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