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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
| Completed |
NCT04136821 -
The Long-term Effects of Oceanix™ on Resistance Training Adaptations
|
N/A | |
| Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
| Completed |
NCT03358524 -
Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia
|
Phase 4 | |
| Recruiting |
NCT05327348 -
Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery
|
Phase 3 | |
| Completed |
NCT03288623 -
The Effects of Dark Chocolate Implementation in Elite Athletes
|
N/A | |
| Completed |
NCT04419025 -
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
|
Phase 2 | |
| Completed |
NCT04597983 -
Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists
|
N/A | |
| Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A | |
| Enrolling by invitation |
NCT03030456 -
Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders
|
N/A | |
| Not yet recruiting |
NCT02202239 -
Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT02256254 -
SIMOX - Induction of Oxidative Stress
|
Phase 2 | |
| Recruiting |
NCT02048592 -
Impact of Immunonutrition on the Patients With Cystic Fibrosis
|
Phase 4 | |
| Completed |
NCT01942460 -
Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients
|
Phase 4 | |
| Completed |
NCT02463318 -
The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects
|
N/A | |
| Completed |
NCT01990391 -
Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities
|
N/A | |
| Completed |
NCT02177383 -
Action of Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance
|
N/A | |
| Completed |
NCT00845130 -
Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes
|
N/A | |
| Completed |
NCT00607893 -
Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea
|
N/A | |
| Active, not recruiting |
NCT00247507 -
The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients
|
Phase 4 |