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Effect of pentoxifylline as an intervention to reduce proteinuria in patients with type 2 of diabetes treated with angiotensin system blockers compared with patients (control group) were treated with ACEI or ARB

Protocol summary

Summary
In this study effect of pentoxifylline, a drug nonselective phosphodiesterase inhibitor, will be measured in patients with diabetes to reduce urinary protein excretion. 32 patients because of proteinuria with type 2 of diabetic chosen or have been admitted from endocrinology and nephrology clinic and divided into two groups. Their questionnaire, including demographic data and etc. will be filled. In Group (1) ACEI and ARB medications used to reduce proteinuria. In the group (2) ACEI and ARB drugs in addition, pentoxifylline. Finally, the results of the two groups in terms of further reduction in proteinuria compared. Patients will be eligible for this prospective study, i.e., they have more than 500 milligrams protein in 24-hour urine excretion and do not have contra-indications of PTX (cerebral hemorrhage, retinal hemorrhage, acute myocardial infarction and hypotension). During the study will not change in glycemic control and treatment plan and if they are taking hypertension medication, drugs will continue unchanged. Baseline patient's blood pressure was measured twice within 10 minutes and fasting blood sugar, U/A, creatinine and urine protein will be tested in 24 hours. Then patients are divided to two groups, half of the patients treat with PTX, ACEI and ARB and half of patients treat with ARB and ACEI for 2 months randomly and Finally clinical and laboratory evaluations will be repeated. Inclusion criteria: patients with type 2 of diabetes; proteinuria greater than 500 mg per 24 hours; people who are treated with ACEI and ARB; patients who do not have contra-indications of PTX. Exclusion criteria: proteinuria less than 500 mg per 24 hours; people who had a history of retinal hemorrhages; who had a history of MI; patients who have contra-indications of PTX; those treated with ACEI and ARB not; people who have hypotension

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111827097N2
Registration date: 2016-12-01, 1395/09/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-01, 1395/09/11
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Ardabil University of Medical Science
Expected recruitment start date
2016-11-30, 1395/09/10
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pentoxifylline as an intervention to reduce proteinuria in patients with type 2 of diabetes treated with angiotensin system blockers compared with patients (control group) were treated with ACEI or ARB
Public title
Effect of pentoxifylline in reducing proteinuria in patients with type 2 of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with type 2 of diabetes; proteinuria greater than 500 mg per 24 hours; people who are treated with ACEI and ARB; patients who do not have contra-indications of PTX. Exclusion criteria: proteinuria less than 500 mg per 24 hours; people who had a history of retinal hemorrhages; who had a history of MI; patients who have contra-indications of PTX; those treated with ACEI and ARB not; people who have hypotension
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 32
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
Ardebil University of Medical Sciences
Street address
Ardebil University of Medical Sciences, University street, Ardabil, Iran
City
Ardebil
Postal code
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
IR.ARUMS.REC.1395.56

Health conditions studied

1

Description of health condition studied
Diabete
ICD-10 code
N08.3
ICD-10 code description
Diabetic nephropathy

Primary outcomes

1

Description
Proteinuria
Timepoint
befor and after the study
Method of measurement
mg/d

Secondary outcomes

1

Description
Urea
Timepoint
befor and after the study
Method of measurement
mg/dl

Intervention groups

1

Description
Case group: Pentoxifylline, Tablet 400mg oral BD for 2 month Losartan, Tablet 50mg oral OD for 2 month Captopril, Tablet 50mg oral BD for 2 month
Category
Treatment - Drugs

2

Description
Control group: Losartan, Tablet 50mg oral OD for 2 month Captopril, Tablet 50mg oral BD for 2 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomini Hospital
Full name of responsible person
Dr Shadab Mirfakhrayi
Street address
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr Manochehr Iranparvar
Street address
Ardebil University of Medical Sciences, University street, Ardabil, Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardebil 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
Ardebil University of Medical Sciences
Full name of responsible person
Dr Shadab Mirfakhrayi
Position
Internal Medicine Assistant
Other areas of specialty/work
Street address
Imam khomini hospital, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 45 3351 2006
Fax
Email
shadabmirfakhrayi@icloud.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr Shadab Mirfakhrayi
Position
Internal Medicine Assistant
Other areas of specialty/work
Street address
Imam Khomini Hospital, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 45 3351 2006
Fax
Email
shadabmirfakhrayi@icloud.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr Shadab Mirfakhrayi
Position
Internal Medicine Assistant
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, University street, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 45 3351 2006
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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