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Effect of vitamin E supplementation on nitrosative and oxidative stress, serum zinc and metabolic status in type 2 diabetics

Protocol summary

Summary
Eighty persons from type 2 diabetic patients (women and men) will be selected at random. 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 dieting intake, 3 days food record will be gathered from each subject 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 and control group also will take one placebo tablet for 8 weeks. Plasma levels of nitrite and nitrate, malondialdehyde, total antioxidant capacity, activity of paraoxonase-1 enzyme, HbA1c, insulin resistant (HOMA-IR), total cholesterol, LDL-C, HDL-C, TG, LDL/HDL, TC/HDL and serum zinc will be assessed in all of studied subjects before and after of intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904263664N2
Registration date: 2010-09-04, 1389/06/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-09-04, 1389/06/13
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
Vice-chancellor for research and Tabriz Nutritional Research center of 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 nitrosative and oxidative stress, serum zinc and metabolic status in type 2 diabetics
Public title
Effect of vitamin E supplementation on nitrosative and oxidative stress, serum zinc and metabolic status 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
N/A
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
metabolic status
Timepoint
before of intervention and 8 weeks after intervention
Method of measurement
blood sampling and analysing with related tests

2

Description
nitrosative stress
Timepoint
before of intervention and 8 weeks after intervention
Method of measurement
blood sampling and analysing with griess

3

Description
oxidative stress
Timepoint
before of intervention and 8 weeks after intervention
Method of measurement
blood sampling and analysing with spectrophotometry

4

Description
level of serum zinc
Timepoint
before of intervention and 8 weeks after intervention
Method of measurement
blood sampling and analysing with spectrophotometry

Secondary outcomes

1

Description
body mass index
Timepoint
before of intervention and 8 weeks after intervention
Method of measurement
measurement of weight and height

2

Description
energy intake
Timepoint
before of intervention, 4 and 8 weeks after intervention
Method of measurement
3 days food record

3

Description
protein intake
Timepoint
before of intervention, 4 and 8 weeks after intervention
Method of measurement
3 days food record

4

Description
carbohydrate intake
Timepoint
before of intervention, 4 and 8 weeks after intervention
Method of measurement
3 days food record

5

Description
fat intake
Timepoint
before of intervention, 4 and 8 weeks after intervention
Method of measurement
3 days food record

6

Description
intake of vitamin E
Timepoint
before of intervention, 4 and 8 weeks after intervention
Method of measurement
3 days food record

7

Description
intake of vitamin C
Timepoint
before of intervention, 4 and 8 weeks after intervention
Method of measurement
3 days food record

8

Description
intake of zinc
Timepoint
before of intervention, 4 and 8 weeks after intervention
Method of measurement
3 days food record

Intervention groups

1

Description
capsule of vitamin E, once a day, after launch
Category
Other

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
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Maryam Rafraf
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
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

2

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

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
Full name of responsible person
Behnaz Bazyun
Position
Other areas of specialty/work
Street address
City
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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