The aim of this study is to determine the effect of pioglitazone on proteinuria in patients with type 2 diabetes and nephropathy. This study is a clinical trial of phase 3, two-blind, single-centered. 60 patients with inclusion criteria: 24-hour urine protein over 250 mg / day or albumin to creatinine ratio greater than 30 mg / g. Exclusion criteria: lack of hypothyroidism and heart failure; HbA1C is less than 8; Blood pressure less than 160/100; Creatinine less than 2; GFR is selected from more than 50 randomly. Patients are divided into two groups of 30. In the first group, pioglitazone is given 30 mg daily for two months and in the control group. Checklists are checked after intervention. 24-hour urine protein and albumin and creatinine respond to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080210222N10
Registration date:2017-08-17, 1396/05/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-17, 1396/05/26
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effect of pioglitazone on decreasing of proteinuria in type II diabetic patients and kidney disease.
Public title
Evaluation of Effect of pioglitazone on decreasing of proteinuria in type II diabetic patients with nephropathy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclution Criteria: 24-hour urine protein over 250 mg / day or the ratio of albumin to creatinine over 30 mg/g Exclusion Criteria: Hypothyroidism and heart failure; HbA1C is less than 8; Blood pressure less than 160/100; Creatinine less than 2; GFR greater than 50
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
shahrekord university of medical sciences, Kashani street, shahrekord
City
Shahrekord
Postal code
IR.SKUMS.REC.1395.39
Approval date
2016-06-19, 1395/03/30
Ethics committee reference number
IR.SKUMS.REC.1395.39
Health conditions studied
1
Description of health condition studied
Diabetic Nephropathy
ICD-10 code
Insulin-de
ICD-10 code description
E10.2
Primary outcomes
1
Description
24-hour urine protein
Timepoint
2 month after intervention
Method of measurement
sampling
Secondary outcomes
1
Description
Albumin level
Timepoint
2month after intervention
Method of measurement
sampling
2
Description
creatinin level
Timepoint
2month after intervention
Method of measurement
sampling
Intervention groups
1
Description
In the first group receive tablet 30 mg pioglitazone daily orally
Category
Treatment - Drugs
2
Description
In the second group receive placebo daily orally
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital in Shahrekord
Full name of responsible person
Ali Momeny
Street address
Parastar street,Hajar Hospital of Shahrekord University of Medical Sciences, shahrekord
City
shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Dr. Kamal Solati
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
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 of Shahrekord University of Medical Science
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
Shahrekord University of Medical Sciences
Full name of responsible person
Ali Momeny
Position
Nephrologist , Professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
Ali.momeny.dr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Ali Momeny
Position
Nephrologist, professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
Ali.momeny.dr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Ali Momeny
Position
Nephrologist, professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
00
Fax
Email
Ali.momeny.dr@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)