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The effect of combination therapy with Ezetimibe and Gemfibrozile on post-prandial hypertriglyceridemia in type 2 Diabetic patients

Protocol summary

Summary
90 subjects with DM 2, HbA1c <8% and the hyper fasting triglyceride (TG> 250 mg / dl) and without any endocrine disease will be selected and after a 14-hfasting , their blood samples will collected to measure total cholesterol , HDL, ApoA, ApoE, FBS, HbA1c, LFT (ALP, AST, ALT), Cr, TSH by a single laboratory. Then each patient will receive Fat load test standard calories contains 50 grams of fat and 650 kg cal (50 grams butter and 45 grams of animal pasteurized palm and 60 grams of lavash bread).Then the nurse of Diabetes Center will categorized subjects randomly. Group 1 will be treated by ezetimibe. 10 mg + gemfibrozil 1200mg, for 2th group, it will be gemfibrozil 1200mg and 3th group will be received 10mg ezetimibe+ 10mg atorvastatin. After completing 6 month period of treatment, subject will be undertaken 14-h fasting and mentioned process will be repeated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105311179N5
Registration date: 2011-06-27, 1390/04/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-06-27, 1390/04/06
Registrant information
Name
Faranak Sharifi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 0815
Email address
zmdrc@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Science
Expected recruitment start date
2011-01-20, 1389/10/30
Expected recruitment end date
2012-04-18, 1391/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination therapy with Ezetimibe and Gemfibrozile on post-prandial hypertriglyceridemia in type 2 Diabetic patients
Public title
Combination therapy with Ezetimibe and Gemfibrozile on post-prandial hypertriglyceridemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The average age of 20-65-HbA1C <8%-hypertriglycemia>250mg/dlِPatients with DM type 2 Exclusion criteria: Treating with antilipid agents, thyroid disease, acute or chronic liver disease, association with other endocrine disease like Acromegaly or cushing , renal dysfunction (GFR<60), Hypertriglyceridemia>1000 and LDL >190mg/dl
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
zanjan metabolic research center,zanjan university of medical science
Street address
Azadi Boulevard-Zanjan University Of Medical Sciences
City
zanjan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
19/3-3/2112

Health conditions studied

1

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

Primary outcomes

1

Description
lipid profile
Timepoint
6 weeks
Method of measurement
labratory

Secondary outcomes

1

Description
Apo protein B
Timepoint
6 weeks
Method of measurement
labratory

2

Description
apo protein A
Timepoint
6 weeks
Method of measurement
labratory

Intervention groups

1

Description
Group1:ezetimibe 10mg plus gemfibrozile 1200mg
Category
Treatment - Drugs

2

Description
Group 2:1200mg gemfibrozile
Category
Treatment - Drugs

3

Description
Group3: ezetimibe 10mg plus atorvastatin 10mg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Zanjan Endocrine Clinic
Full name of responsible person
Dr.faranak. sharifi
Street address
Vali-asr hosopital, Sheikh fazollahe nouri avenue
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan Metabolic Research Center, Zanjan University of medical science
Full name of responsible person
Dr.alireza. biglari,
Street address
Azadi bulvar
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan Metabolic Research Center, Zanjan University of medical science
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
Zanjan Metabolic Diseases Research Center
Full name of responsible person
Dr.Faranak Sharifi
Position
full professor
Other areas of specialty/work
Street address
Vali-e-asr Hospital, shekh fazollahe nouri avenue
City
Zanjan
Postal code
45157-77978
Phone
+98 24 1727 0815
Fax
Email
faranaksharifi@hotmail.com
Web page address
www.zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan Metabolic Research Center
Full name of responsible person
Dr.nima hojehgani
Position
Internal disease resident
Other areas of specialty/work
Street address
Vali-e-asr hospital, Sheikh fazollahe nouri avenue
City
Zanjan
Postal code
Phone
+98 919 410 3059
Fax
Email
dr_nima_hojeghani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Metabolic Disease Research Center
Full name of responsible person
Dr zahra shajari
Position
General physicien
Other areas of specialty/work
Street address
Vali-e- asr hospital, Sheikh fazollahe nouri avenue
City
Zanjan
Postal code
Phone
Fax
Email
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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