Phase 2
N=78
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
Diabetic Nephropathy · Proteinuria · Oxidative Stress
Bottom Line
View on ClinicalTrials.gov: NCT01265563 ↗Enrolled (actual)
78
Serious AEs
6.8%
Results posted
Mar 2017
Primary outcome: Primary: Change From Baseline in Urinary Albumin Excretion — 50.5; -28.13; -4.5; 96.6 mg/g
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine placebo and silibin placebo (Drug); N-acetylcysteine active and silibin placebo (Drug); N-acetylcysteine placebo and silibin active (Drug); N-acetylcysteine active and silibin active (Drug); N-acetylcysteine active + high-dose silibin active (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Urinary Albumin Excretion |
50.5; -28.13; -4.5; 96.6; 353.71 | — |
| SECONDARY Change From Baseline in Hemoglobin-A1c |
0.35; -0.18; 0.72; 0.4; 0.2 | — |
| SECONDARY Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01265563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.