We will investigate the renoprotective efficacy of angiotensin receptor blocker and N-cetyl cystein in prevention or reduction of proteinuria in patients with diabetic nephropathy. In this randomized clinical trial, 70 patients with diabetes type II suffering from renal dysfunction induced proteinuria with serum creatinine more than 1.8mg and urine protein in urinalysis will be recruited. The patients are randomly assigned into intervention or conrol group to receive Angiotensin Receptor Blockers (25mg, twice daily) as well as N-acetylcysteine (600mg, twice daily) or only Angiotensin Receptor Blockers (25 mg twice daily), respectively, for two months. Urine protein will be checked before and two month after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104046123N1
Registration date:2011-04-19, 1390/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-19, 1390/01/30
Registrant information
Name
Seyed Sadraddin Rasi Hashemi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3966
Email address
rasihashemis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-03-22, 1390/01/02
Expected recruitment end date
2011-06-23, 1390/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing administrating ARBs Vs ARB plus N-acetyl cysteine on reducing proteinuria in the patients suffering from type-II diabetes mellitus
Public title
Prevention and treatment of proteinuria in diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willing to participate, no underlying malignancy, creatinin more than 1.8
Exclusion criteria: no any other diseases
Age
From 25 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-11-08, 1389/08/17
Ethics committee reference number
7737/4/5
Health conditions studied
1
Description of health condition studied
Diabetic nephropathy
ICD-10 code
E10, E11,
ICD-10 code description
Glomerular disorder in diabetes mellitus
Primary outcomes
1
Description
Proteinuria.
Timepoint
before intervention and two monthS after treatment
Method of measurement
Urine collection in 24 hrs
Secondary outcomes
1
Description
Hemoglobin A1C
Timepoint
Before intervention and two months after treatment
Method of measurement
taking blood sample
2
Description
Blood suger
Timepoint
Before intervention and two months after treatment
Method of measurement
take blood sample
Intervention groups
1
Description
Intervention group: N-acetylcyctein 600mg twice daily as well as Losartan 25mg twice daily for two months
Category
Treatment - Drugs
2
Description
In control group: Losartan 25 mg twice in day for two month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital, Sina Hospital, Sheikhol Raeis Clinics
Full name of responsible person
Dr. Sadreddin Rasi Hashemi
Street address
Nephrology ward, Emam reza Hospital, Tabriz Univesity of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sadreddin Rasi Hashemi
Street address
Emam Reza Hospital, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sadreddin Rasi Hashemi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nephrology ward, Emam reza Hospital, Tabriz Univesity of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
+98 41 1335 2073
Email
rasihashemis@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sadreddin Rasi Hashemi
Position
Assistant Professsor
Other areas of specialty/work
Street address
Nephrology ward, Emam reza Hospital, Tabriz Univesity of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
rasihashemis@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Sadreddin Rasi Hashemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)