Oxidative Stress Clinical Trial
Official title:
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy.
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.
Oxidative stress and GSH imbalance are major contributors to the pathogenesis of diabetic
nephropathy. Current options for the treatment of oxidative stress in diabetic nephropathy
are limited and only partially effective, thus interest in the development of new strategies
is high.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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