We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Use of Mucomyst to Ameliorate Oxidant Stress in Diabetics With Proteinuria

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.
ClinicalTrials.gov Identifier: NCT00493727
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : May 19, 2008
West Virginia University
Information provided by:
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment
Diabetes Proteinuria Drug: N-acetylcysteine(Mucomyst)

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : September 2006
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1 Drug: N-acetylcysteine(Mucomyst)

Primary Outcome Measures :
  1. 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 :
  1. Reduction of proteinuria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Diabetic with proteinuria

Exclusion Criteria:

  • Allergy to mucomyst and pt on dialysis

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

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

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

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

Additional relevant MeSH terms:
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs