Effect of Vitamin C and Vitamin E Supplementation on Postprandial Oxidative Stress, Inflammatory Markers, Lipid Profile, Insulin and Blood Glucose Level of Type 2 Diabetic Patients
Diabetes mellitus is one of the most wide spread endocrine disorders and among the most important developing health problems. In this study we evaluated the effect of vitamin E and vitamin C supplementation on postprandial glucose, insulin, lipid profiles, oxidative stress and inflammatory markers in type 2 diabetic patients.
45 patients with type 2 diabetes were randomly divided to 3 groups 1)treatment with vitamin E (400IU/day) 2)treatment with vitamin C (1000mg/d) and 3)placebo group. They were supplemented for 6 weeks, after that we measure biochemical parameters in fasting and postprandial state (after a breakfast that was containing 80g fat) the same as the first day of the study. Data analysis was carried out using one way ANOVA with P<0.05 being significant by SPSS software version 11.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904073236N1
Registration date:2010-10-15, 1389/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-15, 1389/07/23
Registrant information
Name
Zohreh Mazloom
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1008
Email address
zmazloom@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
shiraz university of medical sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2009-08-21, 1388/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin C and Vitamin E Supplementation on Postprandial Oxidative Stress, Inflammatory Markers, Lipid Profile, Insulin and Blood Glucose Level of Type 2 Diabetic Patients
Public title
Effect of Vitamin C and Vitamin E Supplementation on Postprandial Oxidative Stress, Inflammatory Markers, Lipid Profile , Insulin and Blood Glucose Level of Type 2 Diabetic Patients
Purpose
Prevention
Inclusion/Exclusion criteria
1- having diabetes
2- normal blood pressur
3- age between 25 to 65
4- having diabetes for maximum 15 years
5- nonsmoker, nonalcoholic
6- not taking vitamin and/or mineral supplement, insulin therapy, lipid lowering, hormone replacement therapy, diuretics or β-blockers and aspirin
7- no history or clinical evidence of overt vascular disease, acute or chronic inflammatory disease and kidney stones
8- no history of radiation therapy
Age
From 25 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
IRAN- Shiraz-Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2009-07-16, 1388/04/25
Ethics committee reference number
88-4600
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
blood glucose fasting and postprandial
Timepoint
4 times, before and 6 weeks after intervention, fasting and postprandial
Method of measurement
Auto analyser
2
Description
Insulin Fasting and postprandial
Timepoint
4 times,before and after intervation, fasting and postprandial
Method of measurement
Radio Immune Assay
Secondary outcomes
1
Description
lipid profile
Timepoint
before and 6 weeks after intervention, fasting and postprandial
Method of measurement
auto analyser
2
Description
Malondialdehyde
Timepoint
before and 6 weeks after intervention
Method of measurement
spectrophotometery
3
Description
high sensetive C-Reactive Protein
Timepoint
before and 6 weeks after intervention, fasting and postprandial
Method of measurement
ELIZA
4
Description
Interlukin-6
Timepoint
before and 6 weeks after intervention, fasting and postprandial
Method of measurement
Radio Immune Assay
Intervention groups
1
Description
placebo intake for 6 weeks
Category
Placebo
2
Description
vitamin C intake 1000mg/pday for 6 weeks
Category
Treatment - Drugs
3
Description
vitamin E intake;400IU/pday for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari clinic
Full name of responsible person
Street address
Shahid Motahari clinic
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Uuniversity Of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Dabaghmanesh
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Uuniversity 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
School of Health and Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Hejazi
Position
Ph.D student of nutrition
Other areas of specialty/work
Street address
School of health and nutrition, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1720 6963
Fax
Email
n20hejazi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of health and nutrition, Shiraz University of Mediccal Sciences
Full name of responsible person
Dr. Zohreh Mazloom
Position
PHD of nutrition, Associate professor of nutrition department
Other areas of specialty/work
Street address
School of health and nutrition, Shiraz University of Mediccal Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1005
Fax
Email
zmazloom@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Hejazi
Position
ph.D student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, School of health and nutrition
City
Shiraz
Postal code
Phone
+98 71 1720 6963
Fax
Email
n20hejazi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)