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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|