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NCT Number: NCT00556465

Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy

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.

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Key information

Conditions

Diabetic Nephropathy Chronic Disease Chronic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mohammad mahdi sagheb

Shiraz, Fars, 0098711, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcysteine

Drug

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

Primary outcomes

  1. Proteinuria

    Time frame: 3 months

Secondary outcomes

  1. blood pressure,serum creatinine,GFR,c-reactive protein,

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy

Important dates

Study start
2007
Study completion
2007
First posted
Nov 12, 2007
Registry last updated
Nov 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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