Protocol summary

Summary
60 patients with diabet type2 and Glycated hemoglobin(HbA1c) equal or graeter 8 and smaller or equal 10 and with Glomerular filtration rate(GFR) equal or greater 30 and smaller or equal 60 will be selected and randomisly will be divided to two groups. For both groups we will start glibenclamide, But only case group will receive pioglitazone. Both control and case group were similar in their age; sex; degree of renal function; glcemic control and all the measurable value. The only difference between them was receiving pioglitazone in case and do not receive in control group. After 3 months proteinuria and inflammation (C-Reactive Protein and Ferritin) and oxidative markers (Malondialdehyde and Total Anti-Oxidant) measure and compared with together.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102115105N1
Registration date: 2014-03-12, 1392/12/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-12, 1392/12/21
Registrant information
Name
Farahnoosh Farnood
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 914 307 9418
Email address
naghavim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pioglitazone on proteinuria, inflammatory and oxidative markers in patient with diabetic nephropathy
Public title
Effect of a lowering blood glucose drug on protein loss with urine in patient with kidney disease due to diabet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (The patient with Diabetic nephropathy with Diabet type2; Glomerular filtration rate equal or greater than 30; Age graeter 18 & smaller 65 years old; Agreement to participate in the study) Exclusion criteria: (Glomerular Filtration Rate smaller than 30; Dyspnea; CHF; Liver failure; General edema; Age smaller than 18 & greater than 65 years old; Body Mass Index equal or greater than 40
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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 of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2014-02-09, 1392/11/20
Ethics committee reference number
92183

Health conditions studied

1

Description of health condition studied
Diabetic nephropathy
ICD-10 code
E10-E14 :
ICD-10 code description
Diabetes mellitus With renal complications

Primary outcomes

1

Description
Proteinuria
Timepoint
Monthly
Method of measurement
24 urin and according to miligram per deciliter

Secondary outcomes

1

Description
Ferritin
Timepoint
Monthly
Method of measurement
Elisa and according to Nanogram per mililiter

2

Description
High sensitivity C- Reactive protein
Timepoint
Monthly
Method of measurement
Elisa according to Nanogram per mililiter

3

Description
Malondialdehyde
Timepoint
Monthly
Method of measurement
Elisa and according to micromol per liter

4

Description
Total antioxidant
Timepoint
Monthly
Method of measurement
Elisa and according to microgram per mililiter

Intervention groups

1

Description
Tablet Pioglitazone, 30 miligram, pathway oeal, daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Farahnoosh Farnood
Street address
Nephrology ward, Emam Reza Hospital, Golgasht Ave.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
AliReza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Farahnooosh Farnood
Position
Internist/ Student of Nephrology
Other areas of specialty/work
Street address
Nephrology ward, Emam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1337 3966
Fax
+98 41 1337 3966
Email
Farnood_farahnosh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farahnoosh Farnood
Position
Internist/ Student of Nephrology
Other areas of specialty/work
Street address
Nephrology ward, Emam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1337 3966
Fax
+98 41 1337 3966
Email
Farnood_farahnoosh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farahnoosh Farnood
Position
Internist/ Student of Nephrology
Other areas of specialty/work
Street address
Nephrology ward, Emam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1337 3966
Fax
+98 41 1337 3966
Email
Farnood_farahnoosh@yahoo.com
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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