Overview
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
Status:
Completed
Completed
Trial end date:
2016-12-01
2016-12-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
VA Office of Research and DevelopmentCollaborator:
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