Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy

NCT00556465 | Completed Phase 2

• 1 other identifier: 3046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy; Chronic Kidney Disease; Diabetes Type 2

Keywords

diabetic nephropathy; proteinuria; antioxidant

Outcome Measures

Primary Outcomes (1)

• Proteinuria

  3 months

Secondary Outcomes (1)

• blood pressure,serum creatinine,GFR,c-reactive protein,

  3 months

Study Arms (2)

A, 1,III

EXPERIMENTAL

in this arm patients took 1200 mg N-acetylcysteine

Drug: N-acetylcysteine

B,2, III

NO INTERVENTION

Interventions

N-acetylcysteine DRUG

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

A, 1,III

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Mohammad mahdi sagheb

Shiraz, Fars, 0098711, Iran

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Proteinuria

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• mohammad mahdi sagheb, MD

  shiraz university of medical science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: January 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 12, 2007

Record last verified: 2007-11

Locations

IR (1)