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Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556465
First Posted: November 12, 2007
Last Update Posted: November 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shiraz University of Medical Sciences
  Purpose

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 Intervention Phase
Diabetic Nephropathy Chronic Kidney Disease Diabetes Type 2 Drug: N-acetylcysteine Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Proteinuria [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • blood pressure,serum creatinine,GFR,c-reactive protein, [ Time Frame: 3 months ]

Enrollment: 60
Study Start Date: January 2007
Study Completion Date: June 2007
Arms Assigned Interventions
Experimental: A, 1,III
in this arm patients took 1200 mg N-acetylcysteine
Drug: N-acetylcysteine
600 mg of effervescent N-acetylcysteine tablet twice per day for three months
No Intervention: B,2, III

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Iran, Islamic Republic of
Mohammad mahdi sagheb
Shiraz, Fars, Iran, Islamic Republic of, 0098711
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Director: mohammad mahdi sagheb, MD shiraz university of medical science
  More Information

ClinicalTrials.gov Identifier: NCT00556465     History of Changes
Other Study ID Numbers: 3046
First Submitted: November 9, 2007
First Posted: November 12, 2007
Last Update Posted: November 12, 2007
Last Verified: November 2007

Keywords provided by Shiraz University of Medical Sciences:
diabetic nephropathy
proteinuria
antioxidant

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Urologic Diseases
Renal Insufficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes