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Effect of high dose versus low dose Atorvastatin therapy on inflammatory & coagulatory factors in type 2 diabetic patients

Protocol summary

Summary
This study is a randomized clinical trial to compare the effects of high-dose atorvastatin with low-dose atorvastatin on inflammatory markers and coagulation profiles in patients with type 2 diabetes. patients with type 2 diabetes over the age of 18 , LDL> 70 and TG <500 , patients are not treated with statins or Stopping the drug (>1 mth) , come to endocrine clinic of Imam Reza (AS) hospital were enrolled after consent . The sample size of this study, according to the results of the yicong, and colleagues study , Hs-CRP changes in the power 80 and a maximum Type I error of 0.05 was determined for each group of 93 samples to increase the validity of study , 100 patients for each group determined. The subjects were randomly divided into 2 groups of 100 people. In the first group, statins at high doses (40 mg) and low-dose statin group (10mg) administered. Initial tests : FBS, HbA1C, AST, ALT, ALP, BUN, Cr, TG, Total chol, LDL.HDL and specific tests: Homocysteine , fibrinogen and IL6 and IL1 done at baseline and then repeated 3 months. the effects of high-dose atorvastatin and low-dose atorvastatin after three months of education, on inflammatory factors and clotting factors are measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201502226710N5
Registration date: 2015-05-22, 1394/03/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-22, 1394/03/01
Registrant information
Name
Mitra Niafar
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
niafarm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor fo research,Tabriz university of Medical sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high dose versus low dose Atorvastatin therapy on inflammatory & coagulatory factors in type 2 diabetic patients
Public title
Effect of high dose versus low dose Atorvastatin therapy on inflammatory & coagulatory factors in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with type2 diabetes mellitus LDL>70 ; age>18y ;TG<500; patients who don't use or stopped statin use (> 1 mth) Exclusion criteria: type 1 diabetes Mellitus; chronic liver disease(liver enzymes more than 3 time the upper limit of normal , B or C Hepatitis ); renal failure Cr>2;pregnancy;lactation ; Chronic inflammatory diseases such as rheumatic diseases (rheumatoid arthritis and systemic lupus erythematosus); Patients with a history of anti-inflammatory drugs; In case of muscle pain and increased risk of rhabdomyolysis in patients with CPK elevation; unwillingness to participate in the study.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
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
Tabriz University of Medical Sciences, Daneshgah Sq
City
Tabriz
Postal code
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
93168

Health conditions studied

1

Description of health condition studied
type 2 diabetic
ICD-10 code
E10,E11,E1
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
low density Lipoprotein
Timepoint
At baseline and after 3 months of treatment
Method of measurement
Test

2

Description
cholestrol
Timepoint
At baseline and after 3 months of treatment
Method of measurement
test

Secondary outcomes

1

Description
inflammatory markers
Timepoint
At baseline and after 3 months of treatment
Method of measurement
test

2

Description
coagulatory factor
Timepoint
At baseline and after 3 months of treatment
Method of measurement
test

Intervention groups

1

Description
In the first group tablet Atorvastatin (40-80 milligram) daily will be prescribed
Category
Treatment - Drugs

2

Description
In the second group tablet Atorvastatin (10-20 milligram) daily will be prescribed
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Clinic of Imam Reza hospital
Full name of responsible person
Dr. vahide Sadra
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences Daneshgah Square Tabriz
Full name of responsible person
Dr Rashidi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue,
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 Daneshgah Square Tabriz
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. Mitra Niafar
Position
Endocrinology and Metabolism / Associate
Other areas of specialty/work
Street address
Imam Reza Hospital, Department of Endocrinology
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
niafarm@TBZmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mitra Niafar
Position
Endocrinology and Metabolism / Associate
Other areas of specialty/work
Street address
Imam Reza Hospital, Department of Endocrinology
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
niafarm@Tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vahideh Sadra
Position
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
00
Fax
Email
sadra.vahideh@yahoo.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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