NCT00493727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 19, 2008

Status Verified

May 1, 2008

Enrollment Period

1.2 years

First QC Date

June 27, 2007

Last Update Submit

May 16, 2008

Conditions

DiabetesProteinuria

Keywords

Oxidative stressN-acetylcysteineNACIsoprostaneProteinuriaDiabetesMucomystalbuminuria

Outcome Measures

Primary Outcomes (1)

  • This research will test the possibility the Mucomyst given by mouth for a month will decrease oxidative stress and slow the disease.

Secondary Outcomes (1)

  • Reduction of proteinuria

Study Arms (1)

1

OTHER
Drug: N-acetylcysteine(Mucomyst)

Interventions

N-acetylcysteine(Mucomyst)DRUG
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic with proteinuria

You may not qualify if:

  • Allergy to mucomyst and pt on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Dayton

Dayton, Ohio, 45428, United States

Location

MeSH Terms

Conditions

Diabetes MellitusProteinuriaAlbuminuria

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammad G. Saklayen, MD

    VA Medical Center, Dayton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

September 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 19, 2008

Record last verified: 2008-05

Locations

US(1)