Aim of this study is to evaluate the effect of vitamin E supplementation on serum Hs-CRP and lipoprotein A in type 2 diabetes mellitus. Eighty persons from type 2 diabetic patients (women and men) will be selected randomly. Ten cc of venous blood sample will be obtained from each patient at the beginning and end of study. Samples will be taken after 12-14 h fasting condition. For evaluation of diet intake, 3 days food record will be gathered from each case prior to the study, 4 weeks after beginning of study and at the end (after 8 weeks) of study. Intervention group will take vitamin E (400 mg) after eating launch for 8 weeks but control group will take one placebo tablet for 8 weeks. Serum levels of vitamin E, Hs-CRP and lipoprotein A will be assessed in all of studied cases before and after the intervention.
Main inclusion criteria:patients under treatment only with oral hypoglycemic agents at least for 6 months; BMI≤35; 30-60 years old.
Main exclusion criteria: pregnancy and lactating;patients who are under treated with insulin,and under treated with hormone; smoking; any change in dose of lowering blood glucose drugs which used by patients during the intervention; taking antioxidant supplements at least 3 months before the beginning of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104043664N4
Registration date:2011-04-16, 1390/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-16, 1390/01/27
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Reseach Center of Tabriz University of Medical Sciences, Vice-chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin E supplementation on serum Hs-CRP and lipoprotein a in type 2 diabetics
Public title
Effect of vitamin E supplementation on serum Hs-CRP and lipoprotein a in type 2 diabetics
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: volunteer for participating in the study; diagnosis of diabetes at least 1 year prior to our examination; patients under treatment only with oral hypoglycemic agents at least for 6 months; BMI≤35; 30-60 years old. Exclusion criteria: pregnancy and lactating; liver, renal, heart, thyroid and inflammation disease; patients who are under treated with insulin, hypolipidemic and diuretic drugs, and who use fish oil or garlic capsules and under treated with hormone; smoking; any change in dose of lowering blood glucose drugs which used by patients during the intervention; taking antioxidant supplements at least 3 months before the beginning of study.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Approval date
2010-07-01, 1389/04/10
Ethics committee reference number
5/4/2528
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
level of serum vitamin E
Timepoint
before of intervention and 8 weeks after intervention
Method of measurement
blood sampling and analysing with HPLC
2
Description
level of serum Hs-CRP
Timepoint
before of intervention and 8 weeks after intervention
Method of measurement
blood sampling and analysing with Immunoturbidimetry
3
Description
level of serum lipoprotein a
Timepoint
before of intervention and 8 weeks after intervention
Method of measurement
blood sampling and analysing with imunotorbidometry
Secondary outcomes
empty
Intervention groups
1
Description
capsule of vitamin E, once a day, after launch
Category
Treatment - Drugs
2
Description
capsule of placebo, once a day, after launch
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
specialized and subspecialized outpatient clinic of Tabriz university of medical sciences
Full name of responsible person
Behnaz Bazyun
Street address
Health and Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Reseach Center of Tabriz University of Medical Sciences
Full name of responsible person
Alireza ostadrahimi
Street address
Health and Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional Reseach Center of Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice-chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohamad Reza Rashidy
Street address
Tabriz University of Medical Sciences, Daneshgah Street
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
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
Behnaz Bazyun
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1666 0750
Fax
Email
b_nutrition@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behnaz Bazyun
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1666 0750
Fax
Email
b_nutrition@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behnaz Bazyun
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1666 0750
Fax
Email
b_nutrition@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)