Protocol summary

Summary
In present study effect of atorvastatin will be investigated in patients with diabetic nephropathy with a history of gestational diabetes by examining proteinuria and renal function. First, 42 patients attending at Emam Reza educational clinical center of Tabriz University of Medical Sciences , who are between 20 to 65 years old, with type 2 diabetes mellitus , history of gestational diabetes mellitus, proteinuria levels lower than 3 g/d and estimated glomerular filtration rate more than 30 mL/min/1.73m2 will be included, and patients with history of use of antioxidant drugs consumption in past 6 months, active smoking, active coronary artery disease in the previous 6 months, diabetic foot, hepatitis, and poorly controlled diabetes will be excluded from study. Then the patients will be divided into two equal intervention and control groups using RandList software. Atorvastatin 10 mg per day will be administered to the patients in the intervention group for 90 days. At the end of the third month, the patients will be asked to stop atorvastatin intake for a month. Meanwhile, for control group exact protocol will be administered using placebo instead of atorvastatin. The main outcomes of the present study include lipid profile, serum creatinine, serum uric acid level and urine protein which will be examined before the intervention and 90 days after intervention. Then the results in these stages will be compared in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016100918946N4
Registration date: 2016-11-30, 1395/09/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-30, 1395/09/10
Registrant information
Name
Reza Piri
Name of organization / entity
Emam Reza educational-medical center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 5372
Email address
reza.piri@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of atorvastatin on proteinuria of type 2 diabetic nephropathy in patients with history of gestational diabetes mellitus
Public title
Effects of atorvastatin on diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 20 to 65 years old; patients with type 2 diabetes mellitus; history of gestational diabetes mellitus; proteinuria levels lower than 3 g/d (nephrotic range); estimated glomerular filtration rate more than 30 mL/min/1.73m2 Exclusion criteria: use of fibrates, statins antagonists, aspirin, allopurinol, β-blockers, pentoxifylline, fish oil, other antioxidant drugs consumption in past 6 months; active smoking; active coronary artery disease in the previous 6 months; diabetic foot; hepatitis; poorly controlled diabetes (Hb-A1c more than 7.5%)
Age
From 20 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 42
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences, Golgasht street, Azadi avenue.
City
Tabriz
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
9/6/911

Health conditions studied

1

Description of health condition studied
Diabetic nephropathy
ICD-10 code
E10.2
ICD-10 code description
Insulin-dependent diabetes mellitus with renal complications

Primary outcomes

1

Description
Lipid profile
Timepoint
Before intervention, 90 days after intervention initiation
Method of measurement
Blood samlple

2

Description
Serum creatinine
Timepoint
Before intervention, 90 days after intervention initiation
Method of measurement
Blood samlple

3

Description
Serum uric acid
Timepoint
Before intervention, 90 days after intervention initiation
Method of measurement
Blood samlple

4

Description
Urine Protein
Timepoint
Before intervention, 90 days after intervention initiation
Method of measurement
Blood samlple

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Atorvastatin 10 mg per day will be administered to the patients in intervention group for 90 days. At the end of the third month, patients will be asked not to use Atorvastatin for a month.
Category
Treatment - Drugs

2

Description
Control group: Daily Placebo will be administered to the patients in control group for 90 days. At the end of the third month, patients will be asked not to use placebo for a month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza medical-educational centre, Tarbiz University of medical sciences
Full name of responsible person
Dr.Parviz Saleh
Street address
Emam Reza educational-medical centre, Golgasht street, Azadi Avenue
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
Dr. Mohammad Reza Rashidi
Street address
Azadi street, Golgasht Avenue, Central campus of Tabriz university of medical science
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
Emam Reza educational-medical center
Full name of responsible person
Dr.Parviz Saleh
Position
Associate professor of tropical and infectious diseases
Other areas of specialty/work
Street address
Emam Reza educational-medical centre, Azadi street, Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
p.zzss@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Emam Reza educational-medical center
Full name of responsible person
Dr. Parviz Saleh
Position
Associate professor of tropical and infectious diseases
Other areas of specialty/work
Street address
Emam Reza educational-medical centre, Azadi street, Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
p.zzss@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Emam Reza educational-medical center
Full name of responsible person
Dr. Parviz Saleh
Position
Associate professor of tropical and infectious diseases
Other areas of specialty/work
Street address
Azadi avenue, Golgasht street, Emam Reza educational-medical center
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
dr.reza.piri@gmail.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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