Skip to content

Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy

Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00556465
Enrollment
60
Registered
2007-11-12
Start date
2007-01-31
Completion date
2007-06-30
Last updated
2007-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Diabetes Type 2, Diabetic Nephropathy

Keywords

diabetic nephropathy, proteinuria, antioxidant

Brief summary

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.

Interventions

DRUGN-acetylcysteine

600 mg of effervescent N-acetylcysteine tablet twice per day for three months

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Diabetic patients with more than 500 mg protein in 24 hours urine protein sample * Males and post-menopausal non-lactating and non-pregnant females. * Age greater than or equal to 30 years of age. * Serum creatinine less than 3.0 mg/dL (265 micromoles per liter) * Willing and able to give informed consent

Exclusion criteria

* Type 1 (insulin-dependent; juvenile onset) diabetes * Patients with known non-diabetic renal disease * Renal allograft * Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study entry * Cerebrovascular accident within 3 months of study entry * New York Heart Association Functional Class III or IV * Known allergies or intolerance to N-acetylcysteine * Untreated urinary tract infection or other medical condition that may impact urine protein values.

Design outcomes

Primary

MeasureTime frame
Proteinuria3 months

Secondary

MeasureTime frame
blood pressure,serum creatinine,GFR,c-reactive protein,3 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026