Use of Mucomyst to Ameliorate Oxidant Stress in Diabetics With Proteinuria - Full Text View

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)

MedlinePlus related topics:

Diabetes Stress

ChemIDplus related topics:

Acetylcysteine

U.S. FDA Resources

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

Further study details as provided by Department of Veterans Affairs:

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

Eligibility

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

Criteria

Inclusion Criteria:

Diabetic with proteinuria

Exclusion Criteria:

Allergy to mucomyst and pt on dialysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493727

Locations


United States, Ohio
	VA Medical Center, Dayton
	Dayton, Ohio, United States, 45428

Sponsors and Collaborators

Department of Veterans Affairs

West Virginia University

Investigators


Principal Investigator:	Mohammad G. Saklayen, MD	VA Medical Center, Dayton

More Information

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

Keywords provided by Department of Veterans Affairs:

Oxidative stress

N-acetylcysteine

NAC

Isoprostane

Proteinuria

Diabetes

Mucomyst

albuminuria

Study placed in the following topic categories:

Signs and Symptoms

Proteinuria

Albuminuria

Urologic Diseases

Urination Disorders

Diabetes Mellitus

Acetylcysteine

Stress

N-monoacetylcystine

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 04, 2008

Sponsors and Collaborators:	Department of Veterans Affairs West Virginia University
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00493727