Use of Mucomyst to Ameliorate Oxidant Stress in Diabetics With Proteinuria

This study has been completed.

First Received on June 27, 2007. Last Updated on May 16, 2008 History of Changes

Sponsor:	Department of Veterans Affairs
Collaborator:	West Virginia University
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00493727

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 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Urine and Urination

Drug Information available for: Acetylcysteine

U.S. FDA Resources

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

No publications provided

Responsible Party:	Saklayen, Mohammad - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov 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 Department of Veterans Affairs:

Oxidative stress
N-acetylcysteine
NAC
Isoprostane

Proteinuria
Diabetes
Mucomyst
albuminuria

Additional relevant MeSH terms:

Diabetes Mellitus
Proteinuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Acetylcysteine
N-monoacetylcystine
Antiviral Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on February 12, 2012