In this study the effect of pentoxifylline on protein excretion rate in type 2 diabetic patients taking losartan and enalapril will be evaluted.100 type 2 diabetic patients with proteinuria,despite taking maximum tolerable dose of above mentioned drugs , will be enrolled.Patients will enter into two groups(losartan+enalapril and losartan+enalapril+pentoxifylline) randomly.The dose of pentoxifylline is 400mg and fixed.Pentoxifylline group patients should not have history or physical signs of intracranial hemorrhage , acute MI and retinal hemorrhage and their urine culture should be negative.The protein excretion rate and HbA1C will be measured in both groups in 3th and 6th month.Blood pressure ,cretinine ,urea , GFR ,and serum potasium are going to be checked monthly.Finally, proteinuria changes will be evaluted in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901013596N1
Registration date:2010-05-20, 1389/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-20, 1389/02/30
Registrant information
Name
Elena Lak
Name of organization / entity
Ahvaz Jundishapur University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 9630
Email address
elenalak@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of medical sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey of additive antiproteinuric effect of pentoxifylline on diabetic nephropathy patients with proteinuria taking losartan and enalapril.
Public title
Effect of pentoxifylline on urinary protein excretion reduction in diabetic nephropathy patients.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion: diabetic nephropathy with GFR more than 30 ml/min and proteinuria more than 150 mg/24h.
exclusion: pentoxifylline sensivity, congestion heart failur, uncontroled HTN, patients that recived new drug with antiprotein effect( non dihydropridine calcium channel blockers, sprinolacton,beta blockers, diuretics) during study.
Age
From 25 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee,Ahvaz Jundishapur University .
Street address
Ahvaz Jundishapur University of medical sciences .
City
Ahvaz
Postal code
Approval date
empty
Ethics committee reference number
43//8/20/پ
Health conditions studied
1
Description of health condition studied
Non-insulin-dependent diabetes mellitust
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
2
Description of health condition studied
Diabetic Nephropathy
ICD-10 code
N08.3
ICD-10 code description
Glomerular disorders in diabetes mellitus
Primary outcomes
1
Description
Proteinuria in diabets patients
Timepoint
3 & 6 month later
Method of measurement
measure of protein in 24h urin collection by using colorimetry