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Use of Mucomyst to Ameliorate Oxidant Stress in Diabetics With Proteinuria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00493727
First Posted: June 28, 2007
Last Update Posted: May 19, 2008
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.
Collaborator:
West Virginia University
Information provided by:
VA Office of Research and Development
  Purpose
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
Diabetes Proteinuria Drug: N-acetylcysteine(Mucomyst)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.

Secondary Outcome Measures:
  • Reduction of proteinuria

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic with proteinuria

Exclusion Criteria:

  • Allergy to mucomyst and pt on dialysis
  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): NCT00493727


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

Responsible Party: Saklayen, Mohammad - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00493727     History of Changes
Other Study ID Numbers: 0030
First Submitted: June 27, 2007
First Posted: June 28, 2007
Last Update Posted: May 19, 2008
Last Verified: May 2008

Keywords provided by VA Office of Research and Development:
Oxidative stress
N-acetylcysteine
NAC
Isoprostane
Proteinuria
Diabetes
Mucomyst
albuminuria

Additional relevant MeSH terms:
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
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