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Comparison of therapeutic effects of Fenofibrate and Gemfibrozil on Lipid profile in patients withType 2 Diabetes Mellitus

Protocol summary

Summary
This study aimed to Comparison of therapeutic effects of Fenofibrate and Gemfibrozil on Lipid profile in patients withType 2 Diabetes Mellitus. sixty patients with type 2 diabetes with Inclusion criteria(LDL<100, TG>200, Non HDL chol >130) will be randomly divided in 2 groups including 30 patients in the group that will be receive Fenofibrate and 30 patients in othe rgroup will be receive Gemfibrozil. After3 , blood samples will be obtained.Lipid profil in each sample will be measured to camparison of therapeutic effects of Fenofibrate and Gemfibrozil on

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201401096710N4
Registration date: 2014-01-24, 1392/11/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-24, 1392/11/04
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
Research deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-20, 1392/09/29
Expected recruitment end date
2014-12-20, 1393/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of Fenofibrate and Gemfibrozil on Lipid profile in patients withType 2 Diabetes Mellitus
Public title
Comparison of therapeutic effects of Fenofibrate and Gemfibrozil on Lipid in patients with Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetes ;LDL chol <100 mg/dl ,TG>200 mg/dl ; Non HDL chol >130 mg/dl. Exclusion criteria: age<18;hypothyroidisim;BMI >30,pregnancy;Lactation ;Liver failure ;Renal failure (GFR<30); HB A1C >8%.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Faculty of Medicine- Daneshgah Ave. Tabriz
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
5/4/7615

Health conditions studied

1

Description of health condition studied
Mixed hyperlipidaemia
ICD-10 code
E78.2
ICD-10 code description
Mixed hyperlipidaemia

2

Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Triglyceride
Timepoint
Before and 3 month after intervention
Method of measurement
paraclinical

2

Description
Cholesterol
Timepoint
Before and 3 month after intervention
Method of measurement
paraclinical

Secondary outcomes

1

Description
Liver aminotransferas(AST & ALT)
Timepoint
Before and 3 month after intervention
Method of measurement
Paraclinical

Intervention groups

1

Description
1oo or 200 mg Fenofibrate Tablet for 3 month
Category
Treatment - Drugs

2

Description
450 or 900 mg Gemfibrozil Tablet for 3 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr .Mitra Niafar
Street address
Imam Reza hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr Seid Kazem Shakori
Street address
Golgasht Street ,Tabriz University of Medical Sciences ,central building II,third floor
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 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mitra Niafar
Position
Associate profeesor- endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital-
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
+98 41 1334 4280
Email
dr-niafar@yahoo.comdr.s.ebrahimian@gmail.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 Mitra Niafar
Position
Associate profeesor- endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
dr-niafar@yahoo.comdr.s.ebrahimian@gmail.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 Sanaz Ebrahimian
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1335 5499
Fax
Email
dr.s.ebrahimian@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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