Effects of hydrochlorthiazide and spironolactone in reducing of proteinuria in patients with diabetic nephropathy treated by angiotensin coverting enzyme inhibitors
This study aim to evaluate the effects of hydrochlorthiazide and spironolactone in reducing of proteinuria in patients with diabetic nephropathy treated by angiotensin coverting enzyme inhibitors. 90 diabetic patients that were treated with angiotensin coverting enzyme inhibitors because of proteinuria and hypertension in Sheikh-el-Raeis clinic will randomly be selected and devided in two groups with 45 members which have same age, gender, proteinuria and GFR. the first group will receive Spironolactone 25 mg/day and the other one Hydrochlirthiazide 25 mg/day. the range of proteinuria, blood pressure,serum urea, creatinin, sodium, potassium and albumin before and 3 month after study will be measured in both groups.
General information
Acronym
TDNS
IRCT registration information
IRCT registration number:IRCT201408083742N2
Registration date:2014-10-15, 1393/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-15, 1393/07/23
Registrant information
Name
Hamid Noshad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 5023
Email address
noshadh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of hydrochlorthiazide and spironolactone in reducing of proteinuria in patients with diabetic nephropathy treated by angiotensin coverting enzyme inhibitors
Public title
Effects of hydrochlorthiazide and spironolactone in tratement of kidney involvement in diabetic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: blood pressure>130/80 under treatment with ACEIs; proteinuria>150 mg/24hr
Exclusion criteria: serum potasium>5 meq/L; GFR<30 ml/min; proteinuria due to other conditions such as UTI or CHF
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Tabriz University of Medical Sciences
Street address
Tabriz, Golgasht street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
51665118
Approval date
2014-07-06, 1393/04/15
Ethics committee reference number
9354
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
proteinuria
Timepoint
before and 3 month after study
Method of measurement
24 hr urine collection
Secondary outcomes
1
Description
blood pressure
Timepoint
before and 1 week and 1 and 3 month after study
Method of measurement
barometer(mmhg)
2
Description
serum potasium
Timepoint
before and 1 week and 1 and 3 month after study
Method of measurement
biochemical test(meq/L)
3
Description
serum sodium
Timepoint
before and 3 month after study
Method of measurement
biochemical test(meq/L)
4
Description
serum cratinin
Timepoint
before and 3 month after study
Method of measurement
biochemical test(mgr/dl)
5
Description
serum urea
Timepoint
before and 3 month after study
Method of measurement
biochemical test(mgr/dl)
6
Description
serum albumin
Timepoint
before and 3 month after study
Method of measurement
biochemical test(gr/dl)
7
Description
24hr urine volume
Timepoint
before and 3 month after study
Method of measurement
biochemical test(mililiter)
8
Description
24hr urine creatinin
Timepoint
before and 3 month after study
Method of measurement
biochemical test(miligram)
9
Description
albumin/creatinin ratio
Timepoint
before and 3 month after study
Method of measurement
biochemical test
10
Description
glumerolar filtration
Timepoint
before and 3 month after study
Method of measurement
Cockcroft-Gault equation
Intervention groups
1
Description
First group: Spironolactone 25 mg daily for 3 month
Category
Treatment - Drugs
2
Description
Second group: Hydrochlorthiazide 25 mg daily for 3 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikh el Raeis clinic
Full name of responsible person
Taher manzary MD
Street address
Azadi avenue, Golgasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Medical Faculty
Full name of responsible person
Hasan Soleimanpour MD
Street address
Medical faculty, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Medical Faculty
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
Dr. Taher Manzary
Position
Internal medicine assistant
Other areas of specialty/work
Street address
Emam reza hospital, Internal medicine group, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3442 9017
Fax
Email
manzarytaher@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
Dr. Taher Manzary
Position
Internal medicine assistant
Other areas of specialty/work
Street address
Emam reza hospital, Internal medicine group, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3442 9017
Fax
Email
manzarytaher@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
Dr. Taher Manzary
Position
Internal medicine assistant
Other areas of specialty/work
Street address
Emam reza hospital, Internal medicine group, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3442 9017
Fax
Email
manzarytaher@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)