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Sponsors and Collaborators: |
Department of Veterans Affairs West Virginia University |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00493727 |
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 |
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Diabetes Proteinuria |
Drug: N-acetylcysteine(Mucomyst) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Use of Mucomyst (NAC) to Ameliorate Oxidant Stress in Diabetic Patients as Measurable by Surrogate Serum Markers |
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 |
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1 | Drug: N-acetylcysteine(Mucomyst) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
VA Medical Center, Dayton | |
Dayton, Ohio, United States, 45428 |
Principal Investigator: | Mohammad G. Saklayen, MD | VA Medical Center, Dayton |
Responsible Party: | Department of Veterans Affairs ( Saklayen, Mohammad - Principal Investigator ) |
Study ID Numbers: | 0030 |
Study First Received: | June 27, 2007 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00493727 |
Health Authority: | United States: Federal Government |
Oxidative stress N-acetylcysteine NAC Isoprostane |
Proteinuria Diabetes Mucomyst albuminuria |
Signs and Symptoms Proteinuria Albuminuria Urologic Diseases Urination Disorders |
Diabetes Mellitus Acetylcysteine Stress N-monoacetylcystine |
Respiratory System Agents Anti-Infective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antiviral Agents Protective Agents |
Pharmacologic Actions Urological Manifestations Expectorants Therapeutic Uses Free Radical Scavengers Antidotes |