Clinical trial NCT00556465: Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy
Official title: Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Nephropathy
Chronic Kidney Disease
Diabetes Type 2
Keywords: diabetic nephropathy
proteinuria
antioxidant
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proteinuria
timeFrame: 3 months
Secondary outcomes:
measure: blood pressure,serum creatinine,GFR,c-reactive protein,
timeFrame: 3 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Mohammad mahdi sagheb
state: Fars
Study officials:
affiliation: shiraz university of medical science
name: mohammad mahdi sagheb, MD
role: STUDY_DIRECTOR
References: