The aim of this randomized, single center, double blind, and placebo controlled study is to assess the effect of pentoxifylline on proteinuria in type 2 diabetic patients. A total of 54 type 2 diabetic patients with proteinuria of more than 500 mg per day treated with ACEI at least for 3 months referred to polyclinic in Shahid Beheshti Hospital, and private clinics of Babol are enrolled and assigned into intervention group receiving Pentoxifylline, 1200 mg per day for 3 months or control group receiving placebo. Proteinuria will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010144941N1
Registration date:2010-12-01, 1389/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-01, 1389/09/10
Registrant information
Name
Farshid Oliaei
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 6490
Email address
f.oliaee@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pentoxifylline on proteinuria of diabetic type 2 patients
Public title
Effect of pentoxifylline on proteinuria of diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetics type 2 with proteinuria more than 500 mg /d under treatment with ACEI for at least 3 months
Exclusion criteria: diabetics type 1, creatinin more than 1.5 mg/dl, systolic blood pressure more than 140 mmHg, Patients on hemodialysis, presence of fever, acute respiratory distress, or acute heart failure, non- diabetic proteinuric glomerulopathies, obstructive urinary stones, confirmed hypersensitivity to caffeine, theophylline or pentoxifylline, recent brain or retinal hemorrhage, recent 3 months use of thiazolidinediones
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Ganjafruz ave., Babol
City
Babol
Postal code
Approval date
2009-12-18, 1388/09/27
Ethics committee reference number
9397
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus, type II
Primary outcomes
1
Description
Proteinuria
Timepoint
before and after intervention
Method of measurement
24 hours urinary protein measurment
Secondary outcomes
1
Description
serum creatinine
Timepoint
Before and after the intervention
Method of measurement
serum cratinine measurement by jaffe method
Intervention groups
1
Description
Control group: placebo as similar tablets 3 times daily oral for 3 months
Category
Placebo
2
Description
Intervention group: pentoxifylline tablet 400 mg 3 times daily orally for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
Street address
City
Babol
2
Recruitment center
Name of recruitment center
Nephrology clinic of Shahid Beheshti hospital
Full name of responsible person
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Amrollah Mostafazadeh
Street address
Vice- chancellery for research,Babol University of Medical Sciences, Ganj Afruz Ave.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?