Status:
COMPLETED
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Diabetic Nephropathy
Proteinuria
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief 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 (...
Detailed Description
Oxidative stress and glutathione (GSH) imbalance are major contributors to the pathogenesis of diabetic nephropathy. Current options for the treatment of oxidative stress in diabetic nephropathy are l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01265563
Start Date
January 1 2011
End Date
December 1 2016
Last Update
October 19 2018
Active Locations (1)
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1
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States, 78229