Leptin, an adipose tissue hormone, is a potential link between insulin resistance and type 2 diabetes in rodent. In humans, the role of Leptin in regulating insulin resistance and type 2 diabetes is also unclear. In this study we investigated the effects of vitamin C and vitamin E on serum levels of Leptin and HOMA-IR in 120 type 2 diabetic patients in pre and post case control study. Inclusion criteria include of patients who had type 2 diabetes and Exclusion criteria include of patients who had liver diseases, Kidney disease, Hypo- or Hyper- thyroidism or used to vitamin C and E, were excluded from the study . This clinical trial study consisting of 40 patients with type 2 diabetes who has received 1000 mg vitamin C as vitamin C group and 40 patients with type 2 diabetes who has received 400 IU vitamin E as vitamin E group and 40 patients with type 2 diabetes who has not received any things as a control group for 4 weeks. Before and after intervention glucose ,profile lipids ,insulin,hs-CRP, HOMA-IR and serum Leptin in three groups were measured by standard method. The results were analyzed by students T-test and Anova.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202208025N3
Registration date:2012-03-14, 1390/12/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-14, 1390/12/24
Registrant information
Name
Mohammad Ali Ghaffari
Name of organization / entity
Ahwaz Joundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 7192
Email address
ghaffari@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research(Research and Technology), Ahwaz Jondishapur University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamins E and C on the serum levels of leptin and inflammation factors in type II diabetic patients
Public title
The effect of vitamins E and C on the serum levels of leptin and inflammation factors in type II diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients who had type 2 diabetes. Exclusion criteria: Patients who had liver diseases; Kidney disease; Hypo- or Hyper- thyroidism; myocard infraction or blood disorders and used to drugs containing estrogen; progesterone; Diuretics; lower blood pressure and vitamin C and E; were excluded from the study .......
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics Committee Ahwaz Jondishapur University of Medical Sciences
Street address
Ethics Committee Ahwaz Jondishapur University of Medical Sciences
City
Ahwaz
Postal code
6135715794
Approval date
2011-02-26, 1389/12/07
Ethics committee reference number
ETH-133
Health conditions studied
1
Description of health condition studied
Diabetic mellitus 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Leptin
Timepoint
Before and one month after the intervention
Method of measurement
by ELIZA method (ng/ml)
Secondary outcomes
1
Description
Cholestrol
Timepoint
Before and one month after the intervention
Method of measurement
Autoanalyzer (mg/dl)
Intervention groups
1
Description
GROUP 1: consumption of 1000 mg of vitamin C per day for 4 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ashraf Azizollahi
Street address
Golestan Hospital next to Diabetes Research Center,Ahwaz Jondishapur University of Medical Sciences, Shahre Daneshgahi,
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research (Research and technology),Ahwaz Jondishapur University of Medical Sc
Full name of responsible person
Dr. Mostafa Feghi
Street address
Postbox 45, Postcode 6135715794, Vice chancellor for research(Research and technology), Ahwaz Jondishapur University of Medical Sciences, Shahre Daneshgahi,
City
Ahwaz
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 (Research and technology),Ahwaz Jondishapur University of Medical Sc
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
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Mozhgan Noor Behbahani
Position
Expert of Laboratory Sciences
Other areas of specialty/work
Street address
Department of Biochemistry,School of Medicine,Ahwaz Jondishapur University of Medical Sciences, Shahre Daneshgahi,
City
Ahwaz
Postal code
6135715794
Phone
+98 61 1378 2914
Fax
+98 61 1378 2914
Email
mozhgannoorb@yahoo.com
Web page address
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Person responsible for scientific inquiries
Contact
Name of organization / entity
cellular and molecular research center
Full name of responsible person
Mohammad Ali Ghaffari
Position
Biochemistry Ph.D.
Other areas of specialty/work
Street address
Department of Biochemistry, School of Medicine, Ahwaz Jondishapur University of Medical Sciences, Shahre Daneshgahi
City
Ahwaz
Postal code
6135715794
Phone
+98 61 1337 7192
Fax
+98 61 1333 2036
Email
ghaffarima@yahoo.com; ghaffari@ajums.ac.ir
Web page address
-----------------------
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Joundishapour University of Medical Sciences
Full name of responsible person
Mozhgan Noor Behbahani
Position
Expert of Laboratory Sciences
Other areas of specialty/work
Street address
Department of Biochemistry,School of Medicine,Ahwaz Jondishapur University of Medical Sciences, Shahre Daneshgahi
City
Ahwaz
Postal code
6135715794
Phone
+98 61 1378 2914
Fax
+98 61 1333 2036
Email
mozhgannoorb@yahoo.com
Web page address
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Sharing plan
Deidentified Individual Participant Data Set (IPD)