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Anti Micro Albuminuric Effect of Spironolatone with or without Losartan in Diabetic type II Patients

Protocol summary

Summary
This study will do in 35-75 years old diabetic patient with microalbuminuria. Exclusion criteria: 1) systolic blood pressure > 180mmHg; 2)Diastolic blood pressure > 110mmHg; 3)Serum k > 5.5 mg/dl; 4)CVA or MI in 6 month ago; 5)Treatment whit corticosteroids, NSAIDs, immunosuppressive; 6)Patients whit renovascular disease, obstructive uropathy, collagenous disease, malignancy, alcohol users, addiction; 7)Pregnant or breast fed women; 8)HbA1C > 8%. Sample is 60 persons that will study for 12 weeks. The patients will be divided in 2 groups: First group intake spironolactone 25mg daily plus placebo ½ tablet twice daily; Second group intake spironolactone 25mg daily whit plus losartan 12.5mg twice daily. Blood pressure, Na, K, urea, Cr, will be checked every 4weeks. Microalbuminuria will be measured in the beginning and end of study. We expect microalbuminuria will improve or decrease less than half after 12 weeks treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138806211241N2
Registration date: 2012-01-18, 1390/10/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-18, 1390/10/28
Registrant information
Name
Atieh Makhlough
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 4047
Email address
dr.makhloogh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anti Micro Albuminuric Effect of Spironolatone with or without Losartan in Diabetic type II Patients
Public title
Anti Micro Albuminuric Effect of Spironolatone with or without Losartan in Diabetic type II Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: This study will done in 35-75 years old diabetic patient with microalbuminuria. Exclusion criteria: 1)systolic blood pressure > 180mmHg; 2)Diastolic blood pressure > 110mmHg; 3)Serum k > 5.5 mg/dl; 4)CVA or MI in 6 month ago; 5)Treatment whit corticosteroids, NSAIDs, immunosuppressive; 6)Patients whit renovascular disease, obstructive uropathy, collagenous disease, Malignancy, alcohol users, addiction; 7)Pregnant or breast fed women; 8)HbA1C > 8%.
Age
From 35 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
No.2 Building Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
Approval date
2010-09-30, 1389/07/08
Ethics committee reference number
88-89

Health conditions studied

1

Description of health condition studied
micrialbuminuria in diabetic type 2
ICD-10 code
N08.3
ICD-10 code description
Glomerular disorders in diabetes mellitus

Primary outcomes

1

Description
Measurement of urinary microalbuminuria
Timepoint
Before treatment and 12 weeks after treatment
Method of measurement
Laboratory

Secondary outcomes

1

Description
Measurement of sodium
Timepoint
Before treatment, 4, 8 and 12 weeks after treatment
Method of measurement
Lablatory

2

Description
Potassium
Timepoint
Before treatment, 4, 8 and 12 weeks after treatment
Method of measurement
Laboratory

3

Description
Creatinine
Timepoint
Before treatment, 4, 8 and 12 weeks after treatment
Method of measurement
Lablatory

4

Description
Urea
Timepoint
Before treatment, 4, 8 and 12 weeks after treatment
Method of measurement
Lablatory

5

Description
Hypertension
Timepoint
Before treatment, 4, 8 and 12 weeks after treatment
Method of measurement
The barometer

Intervention groups

1

Description
Intervention groups: spironolactone 25 mg daily plus losartan 12.5 twice daily
Category
Treatment - Drugs

2

Description
Control group: spironolactone 25 mg with placebo half tablet twice daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Atieh Makhlough
Street address
Clinic of Nephrology and Diabetes, Imam Khomeini Hospital, Razi Avenue
City
Sari

2

Recruitment center
Name of recruitment center
Tooba Clinic
Full name of responsible person
Dr Atieh Makhlough
Street address
Tuba specialist clinic, Caspian Boulevard
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
No.2 Building, Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Atieh Makhlough
Position
Nephrologist/Associate Professor
Other areas of specialty/work
Street address
Clinic of Nephrology and Diabetes, Imam Khomeini Hospital, Razi Avenue
City
Sari
Postal code
Phone
+98 15122617004
Fax
Email
dr.makhloogh@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Atieh Makhlough
Position
Nephrologist/Associate Professor
Other areas of specialty/work
Street address
Clinic of Nephrology and Diabetes, Imam Khomeini Hospital, Razi Avenue
City
Sari
Postal code
Phone
+98 15 1325 7230
Fax
Email
dr.makhloogh@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Atieh Makhlough
Position
Nephrologist
Other areas of specialty/work
Street address
Clinic of Nephrology and Diabetes, Imam Khomeini Hospital, Razi Avenue
City
Sari
Postal code
Phone
Fax
Email
dr.makhloogh@mazums.ac.ir
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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