N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy
NCT ID: NCT00915200
Last Updated: 2016-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
114 participants
INTERVENTIONAL
2009-10-31
2016-04-30
Brief Summary
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Detailed Description
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The study intends to test the hypothesis that combined oral supplementation of the antioxidants N-acetylcysteine (NAC) and milk thistle flavonolignan silibin (as silibin-phosphatidylcholine) will reduce proteinuria and urinary and systemic manifestations of oxidative stress and inflammation, which are characteristically observed in patients with type 2 diabetes mellitus and related nephropathy. We expect these effects to be achieved with minimal or no side effects, and with good patient tolerance.
The trial is designed as a two-center, double-blind, placebo-controlled, randomized, modified-factorial dose-ranging design, five-arm pilot study in patients with Type 2 diabetes mellitus and advanced diabetic nephropathy with proteinuria.
Intervention consists of three-month oral administration of NAC, silibin, and/or respective placebos for three months. Subjects are randomized to the following five intervention arms: (A) placebo; (B) NAC; (C) silibin; (D) NAC + silibin; and (E) NAC + double-dose silibin.
The primary outcome measure is urinary excretion of albumin, a marker of glomerular injury. Secondary outcome measures are alpha-1 microglobulin, a marker of tubular injury, and urinary excretion of inflammatory cytokines and C-C chemokines, i.e. markers of renal inflammation. In addition, peripheral blood monocytes from the same patients are analyzed for glutathione (GSH) content and activity of GSH metabolizing enzymes. All outcome measures are monitored in relation to both treatment allocation and prevalent blood and urine levels of the active treatment. Safety and tolerability of this combination treatment are monitored throughout the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
N-acetylcysteine placebo + silibin placebo
N-acetylcysteine placebo
excipient orally twice daily for three months
silibin placebo
excipient orally twice daily for three months
N-acetylcysteine
N-acetylcysteine active + silibin placebo
N-acetylcysteine
600 mg orally twice daily for three months
silibin placebo
excipient orally twice daily for three months
silibin
N-acetylcysteine placebo + silibin active
silibin
480 mg orally twice daily for three months
N-acetylcysteine placebo
excipient orally twice daily for three months
silibin placebo
excipient orally twice daily for three months
N-acetycysteine + silibin
N-acetylcysteine active + silibin active
N-acetylcysteine
600 mg orally twice daily for three months
silibin
480 mg orally twice daily for three months
silibin placebo
excipient orally twice daily for three months
N-acetylcysteine + high-dose silibin
N-acetylcysteine active + high-dose silibin active
N-acetylcysteine
600 mg orally twice daily for three months
high-dose silibin
960 mg orally twice daily for three months
Interventions
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N-acetylcysteine
600 mg orally twice daily for three months
silibin
480 mg orally twice daily for three months
high-dose silibin
960 mg orally twice daily for three months
N-acetylcysteine placebo
excipient orally twice daily for three months
silibin placebo
excipient orally twice daily for three months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
VA Office of Research and Development
FED
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Paolo Fanti, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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University of Texas Hlth Sci Ctr San Ant
San Antonio, Texas, United States
Countries
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References
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Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
Other Identifiers
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