N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Nephropathy, Proteinuria, Oxidative Stress

In brief

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.

Key facts

Study ID

NCT01265563

Run by

VA Office of Research and Development

People needed

108

Starts

2011-01-01

Expected to finish

2016-12-01

Last updated by the study team

2018-10-19

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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