Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy
Information source: Shiraz University of Medical Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Nephropathy; Chronic Kidney Disease; Diabetes Type 2
Intervention: N-acetylcysteine (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Shiraz University of Medical Sciences Official(s) and/or principal investigator(s):
mohammad mahdi sagheb, MD, Study Director, Affiliation: shiraz university of medical science
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.
Clinical Details
Official title: Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Proteinuria
Secondary outcome: blood pressure,serum creatinine,GFR,c-reactive protein,
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Mohammad mahdi sagheb, Shiraz, Fars 0098711, Iran, Islamic Republic of
Additional Information
Starting date: January 2007
Ending date: June 2007
Last updated: November 9, 2007
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