Overview

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