Use of Mucomyst to Ameliorate Oxidant Stress in Diabetics With Proteinuria

This study has been completed.
West Virginia University
Information provided by:
VA Office of Research and Development Identifier:
First received: June 27, 2007
Last updated: May 16, 2008
Last verified: May 2008

The study will look at the effect of 30 days of treatment of 15 diabetics with proteinuria with N-acetylcysteine ( Mucomyst ) at a dose of 1 gm twice a day by mouth. The primary outcome that will be measured is change in the oxidant stress as measurable by changes in the serum level of isoprostane, Glutathione peroxidase, aconitase and Total oxidant stress. Secondary outcomes measured will be changes in proteinuria and kidney function as measured by spot urine pr/cr and estimated GFR by MDRD formula.

Condition Intervention
Drug: N-acetylcysteine(Mucomyst)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Mucomyst (NAC) to Ameliorate Oxidant Stress in Diabetic Patients as Measurable by Surrogate Serum Markers

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • This research will test the possibility the Mucomyst given by mouth for a month will decrease oxidative stress and slow the disease. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of proteinuria [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: N-acetylcysteine(Mucomyst)

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diabetic with proteinuria

Exclusion Criteria:

  • Allergy to mucomyst and pt on dialysis
  Contacts and Locations
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Please refer to this study by its identifier: NCT00493727

United States, Ohio
VA Medical Center, Dayton
Dayton, Ohio, United States, 45428
Sponsors and Collaborators
VA Office of Research and Development
West Virginia University
Principal Investigator: Mohammad G. Saklayen, MD VA Medical Center, Dayton
  More Information

No publications provided

Responsible Party: Saklayen, Mohammad - Principal Investigator, Department of Veterans Affairs Identifier: NCT00493727     History of Changes
Other Study ID Numbers: 0030
Study First Received: June 27, 2007
Last Updated: May 16, 2008
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Oxidative stress

Additional relevant MeSH terms:
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Anti-Infective Agents
Antiviral Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses processed this record on October 09, 2015