Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy
|ClinicalTrials.gov Identifier: NCT00556465|
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : November 12, 2007
Diabetic nephropathy has become the single most frequent cause of end-stage renal disease.
On a molecular level, at least five major pathways have been implicated in glucose-mediated vascular and renal damage and all of these could reflect a single hyperglycaemia-induced process of overproduction of reactive oxygen species.
Recent studies have shown that inflammation, and more specifically pro-inflammatory cytokines play a determinant role in the development of micro- vascular diabetic complications, most of the attention has been focused on the implications of TNF-α in the setting of diabetic nephropathy.
Glutathione is the most abundant low-molecular-weight thiol, and Glutathione/ glutathione disulfide is the major redox couple in animal cells.
N-acetylcysteine is effective precursors of cysteine for tissue Glutathione synthesis.
Not only does N-acetylcysteine exhibit antioxidant properties, but it may also counteract the glycation cascade through the inhibition of oxidation.
N-acetylcysteine can also reduce the apoptosis elicited by reactive oxygen species .
Indeed, N-acetylcysteine has been shown to inhibit reactive oxygen species induced mesangial apoptosis and to be able to protect cells from glucose-induced inhibition of proliferation.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy Chronic Kidney Disease Diabetes Type 2||Drug: N-acetylcysteine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy|
|Study Start Date :||January 2007|
|Study Completion Date :||June 2007|
Experimental: A, 1,III
in this arm patients took 1200 mg N-acetylcysteine
600 mg of effervescent N-acetylcysteine tablet twice per day for three months
|No Intervention: B,2, III|
- Proteinuria [ Time Frame: 3 months ]
- blood pressure,serum creatinine,GFR,c-reactive protein, [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556465
|Iran, Islamic Republic of|
|Mohammad mahdi sagheb|
|Shiraz, Fars, Iran, Islamic Republic of, 0098711|
|Study Director:||mohammad mahdi sagheb, MD||shiraz university of medical science|