Comparison of efficacy of low dose of Atorvastatin and Rosuvastatin versus high dose of Atorvastatin and Rosuvastatin in reducing hs-CRP and IL-6 in diabetic patient referred to the Institute of Endocrinology and Metabolism
Efficacy of the low dose vs high dose of Atorvastatin and Rosuvastatin in reducing hs-CRP, IL-6 in diabetic patients.
Design
patients are randomized in to 4 groups
each groups contain 25 diabetic patients:
First group with Atorvastatin 20 mg daily
2th group with Atorvastatin 40 mg daily
3th group with Rosuvastatin 10 mg daily
4th group with Rosuvastatin 20 mg daily
Settings and conduct
Diabetic patients aged between 40 to 75 y/o referring to Institute Endocrinology and Metabolism are randomly categorize in different groups
Participants/Inclusion and exclusion criteria
Diabetic patients between 40 to 75 y/o
Intervention groups
Diabetic patients between 40-75 y/o
Main outcome variables
Highly Sensitive C-Reactive Protein , Interleukin 6
General information
Reason for update
Acronym
IL-6: Interleukin 6 hs-CRP:High sensivity C-Reactive Protein
IRCT registration information
IRCT registration number:IRCT20180929041169N2
Registration date:2019-01-10, 1397/10/20
Registration timing:registered_while_recruiting
Last update:2019-01-10, 1397/10/20
Update count:0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Mohammad taghi Gorji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8603 6064
Email address
malek.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of low dose of Atorvastatin and Rosuvastatin versus high dose of Atorvastatin and Rosuvastatin in reducing hs-CRP and IL-6 in diabetic patient referred to the Institute of Endocrinology and Metabolism
Public title
Comparison of efficacy of low vs. high dose of Atorvastatin and Rosuvastatin in reducing hs-CRP and IL-6 in diabetic patient referred to the Institute of Endocrinology and Metabolism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients who need to receive Statin according to ADA 2018
Exclusion criteria:
Pregnancy
Patient with Genetic Disease
Use of other lowering agent other than Statin
Hx of Angina
Hx of Nephropathy
Hx of Hypothyroidism
Hx of liver Disease or ALT> 3 ULN,AST>3 ULN
CPK> 10 ULN
Patients on Corticosteroids
Patients with Cyclosporins or Hormone replacement therapy
Hx of use of Alcohol
Acute and chronic infectious or Inflammatory disease
Age
From 40 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patient are Randomized in to 4 groups
each groups contain 25 patients:
First group with Atorvastatin 20 mg daily
2th group with Atorvastatin 40 mg daily
3th group with Rosuvastatin 10 mg daily
4th group with Rosuvastatin 20 mg daily
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 IRAN University of Medical Sciences
Street address
Iran University of Medical Sciences,Shahid Hemmat Highway,Tehran,IRAN
City
TEHRAN
Province
Tehran
Postal code
1449614535
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC..1397.196
Health conditions studied
1
Description of health condition studied
Efficacy of low dose and high dose Atorvastatin and Rusovastatin in Diabetic patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of highly sensitive C reactive protein & Interleukin-6
Timepoint
At the initial and 2 month after medication used
Method of measurement
Blood sampling with Elisa assay
Secondary outcomes
empty
Intervention groups
1
Description
Diabetic patients between 40 to 75 years old(no use of lower lipid drugs in past 2 month) are divided to four groups. Each group contains 25 patients. 1st group of intervention will receive 20 mg Atorvastatin (Abidi company) daily, after 2 months the level of IL-6 and hs-CRP will be measured and their decreased is compared between high and low intensity Statins.
Category
Treatment - Drugs
2
Description
Intervention group: 2nd group of intervention will receive 40 mg Atorvastatin (Abidi company) every day. After 2 months IL-6 and hs-CRP level will be measured and the decresed level of them will be compared between high and low intensity Statins.
Category
Treatment - Drugs
3
Description
Intervention group: 3rd group of intervention will receive the daily dose of 10 mg Rosuvastatin (Abidi company) , and after 2 months IL-6 and hs-CRP level will be measured and compared between high and low intensity Statins, as well .
Category
Treatment - Drugs
4
Description
Intervention group: 4th group of intervention will receive 20 mg Rosuvastatin for each day (Abidi company). The IL-6 and hs-CRP level of mentioned patients will be measured and compared between high and low intensity Statins, after 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Institute of Endocrinology and Metabolism affiliated to Iran University of Medical Sciences
Full name of responsible person
Mohamad Taghi Gorji
Street address
Institute of Endocrinology and Metabolism,No 10,Firoozeh Alley, Valieasr Avenue,Tehran
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8603 6064
Fax
+98 21 8894 5173
Email
iem@iums.ac.ir
Web page address
http://iem.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Kazem Malakouti
Street address
Iran University of Medical Sciences,next to Milad Tower,Hemat Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
+98 21 8805 2248
Email
PR@iums.ac.ir
Web page address
http://iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamad Taghi Gorji
Position
Internist,Subspecialist Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No 10, Firoozeh alley, Valieasr avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8603 6064
Fax
+98 21 8894 5173
Email
dr.hgorji@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Malek
Position
Endocrinologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 10, Firoozeh alley, Valieasr avenue,Tehran
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8603 6064
Fax
+98 21 8894 5173
Email
malek.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamad Taghi Gorji
Position
Internist , Subspecialist Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No 10, Firoozeh Alley, Valieasr Avenue,Tehran
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8603 6064
Fax
+98 21 8894 5173
Email
dr.hgorji@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available