N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Nephropathies, Proteinuria, Oxidative Stress

In brief

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 urine protein, the oxidative stress, and the inflammation in patients with type 2 diabetes mellitus and diabetic kidney disease.

Key facts

Study ID

NCT00915200

Run by

The University of Texas Health Science Center at San Antonio

People needed

114

Starts

2009-10-01

Expected to finish

2016-04-01

Last updated by the study team

2016-06-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Texas Hlth Sci Ctr San Ant — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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