Oxidative Stress Clinical Trial
Official title:
Correction of Glutathione Deficiency for Treatment of Diabetic Nephropathy
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.
Oxidative stress and glutathione (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
T2DM and related nephropathy. The investigators 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 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.
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