Our aim in this study is comparison of two treatment regimens in reduction of proteinuria in type 2 diabetic patients. In a randomized unicentral trial 44 patients with type two diabetes from both genders and referring to the nephrology clinic of Emam Reza hospital, Tabriz, Iran were assigned in 2 equal-sized groups to receive oral losartan 25 mg BID or losrtan with the same dose together with pyridoxamine 25 mg/day. The key inclusion criteria were to be 18 to 70 years old; to have type 2 diabetes; 24 hours urine albumin more than 300 mg/dl or to have a albumin to creatinine ratio of more than 30. The key exclusion criteria were to have a history of diabetic ketoacidosis; and to have a history of sensitivity to the Vitamin B group drugs. Renal function status based on serum creatinine, urea, sodium, potassium, triglyceride, cholesterol and uric acid together with urine creatinine and 24 hours urine albumin and protein before and after treatment will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121311743N1
Registration date:2012-12-31, 1391/10/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-31, 1391/10/11
Registrant information
Name
Kamaleddin Golbazi
Name of organization / entity
Tariz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5921
Email address
golbazik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-12-09, 1391/09/19
Expected recruitment end date
2013-06-08, 1392/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Losartan with combination of Losartan and pyridoxamine on proteinuria in type 2 diabetic patients
Public title
Comparison of two treatment regimens in reduction of proteinuria in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (to be 18 to 70 years old; to have type 2 diabetes; 24 hours urine albumin more than 300 mg/dl or to have a albumin to creatinine ratio of more than 30; not to have a nephropathy due to other diseases)
Exclusion criteria: (patients with advanced cardiac or cerebral diseases; to have a history of diabetic ketoacidosis and to have a history of sensitivity to the Vitamin B group drugs)
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Postal code
Approval date
2012-12-08, 1391/09/18
Ethics committee reference number
91156
Health conditions studied
1
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
Serum creatinine level
Timepoint
Before and after treatment
Method of measurement
Lab
2
Description
Serum sodium level
Timepoint
before and after treatment
Method of measurement
Lab
3
Description
Serum potassium level
Timepoint
before and after treatment
Method of measurement
Lab
4
Description
Serum urea level
Timepoint
before and after treatment
Method of measurement
Lab
5
Description
Serum cholesterol level
Timepoint
before and after treatment
Method of measurement
Lab
6
Description
Serum uric acid level
Timepoint
before and after treatment
Method of measurement
Lab
7
Description
serum triglyceride level
Timepoint
before and after treatment
Method of measurement
Lab
8
Description
Urine creatinine level
Timepoint
before and after treatment
Method of measurement
Lab
9
Description
24 hours urine albumin level
Timepoint
before and after treatment
Method of measurement
Lab
10
Description
24 hours urine protein level
Timepoint
before and after treatment
Method of measurement
Lab
Secondary outcomes
empty
Intervention groups
1
Description
For group Losartan: Losartan 25 mg tablets will be administered two times a day for 2 months.
Category
Treatment - Drugs
2
Description
For group Losartan plus pyridoxamine: Losartan tablets 25 mg two times a day together with Pyridoxamine tablets 25 mg once a day will be administered for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology clinic of Emam Reza hospital
Full name of responsible person
Seyyed Sadreddin Hashemi Rasi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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 square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Kamaleddin Golbazi
Position
Resident of internal diseases
Other areas of specialty/work
Street address
Internal diseases ward, Imam Reza hospital, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
golbazik@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
Kamaleddin Golbazi
Position
Resident of internal diseases
Other areas of specialty/work
Street address
Internal diseases ward, Imam Reza hospital, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
golbazik@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
Mehdi Hemmati
Position
General physician
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)