Status:
COMPLETED
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
VA Office of Research and Development
Conditions:
Diabetic Nephropathies
Proteinuria
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The study is designed to test if the combination of two potent antioxidant nutritional supplements, N-acetylcysteine and the milk thistle extract silibin, is capable of correcting the shedding of urin...
Detailed Description
Oxidative stress and GSH imbalance are major contributors to the pathogenesis of diabetic nephropathy. Current options for the treatment of oxidative stress in diabetic nephropathy are limited and onl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00915200
Start Date
October 1 2009
End Date
April 1 2016
Last Update
June 27 2016
Active Locations (1)
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1
University of Texas Hlth Sci Ctr San Ant
San Antonio, Texas, United States, 78229