Protocol summary

Summary
Visfatin is an adipocytokines which is secreted from adipose tissue and can be effective on the diabetes inflammatory reaction and also serum lipids level. On the other hand, Omega-3 can reduce the fats and also can prevent form insulin resistance. In the present study, the effect of Omega-3 on the serum visfatin concentration compared with placebo has been reviewed. A total of seventy-one women with type II diabetes in two groups had been under the treatment with Omega-3 capsules and the control group with placebo capsules. In the first step, the study subjects filled in a questionnaire including age, height, weight, waist circumference, hip circumference; besides, their blood sample were taken for the blood tests. In the second step, the intervention was done for 8 weeks and in the third step the above mentioned data and also blood sample were received again. Hip circumference was measured from the middle and the largest part of it and waist circumference also from the cord at the end of a normal exhalation. In the blood samples, the following parameters were measured: visfatin and lipid profiles (LDL: low density lipoprotein, HDL: high density lipoprotein, TG: triglyceride and cholesterol), glucose and HbA1c via a special measuring kit.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903164109N1
Registration date: 2011-06-03, 1390/03/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-03, 1390/03/13
Registrant information
Name
Hossein Hajianfar
Name of organization / entity
Tehran Medical Sience University
Country
Iran (Islamic Republic of)
Phone
+98 31 1951 3172
Email address
hajianfar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2009-11-22, 1388/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Omega3 on serum Visfatin concentration in patiants with type 2 diabete.
Public title
Effect of Omega3 on serum Visfatin concentration
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: type II diabetic women with at least five years past from their diagnosis; women who were volunteers for participating in the study. Exclusion criteria: insulin injection, secondary complications of diabetes such as ophthalmic and renal complication, amputation, diseases caused by diabetes complications such as kidney disease, amputation, blindness, heart diseases, and inflammatory disease in which CPR level was +++ or more.
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 71
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
N/A

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran Medical Sience University
Street address
Enghelan St 16 Azar
City
Tehran
Postal code
8143873333
Approval date
2008-04-10, 1387/01/22
Ethics committee reference number
10160

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
non-insulin-dependent

Primary outcomes

1

Description
Visfatin
Timepoint
befor and after trial
Method of measurement
special Lab kit

Secondary outcomes

1

Description
TG
Timepoint
befor and after intervention
Method of measurement
pars azmoon kit

2

Description
HbA1c
Timepoint
befor and after intervention
Method of measurement
pars azmoon kit

3

Description
Cholestrol
Timepoint
befor and after intervention
Method of measurement
pars azmoon kit

4

Description
FBS
Timepoint
befor and after intervention
Method of measurement
pars azmoon kit

5

Description
HDL
Timepoint
befor and after intervention
Method of measurement
pars azmoon kit

6

Description
LDL
Timepoint
befor and after intervention
Method of measurement
pars azmoon kit

Intervention groups

1

Description
2 Omega3 capsules a day (1000 mg oil include 360 mg EPA and 240 mg DHA)
Category
Prevention

2

Description
2 Placebo Capsules a day (1gr corn starch)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Institude Of diabetes charity Isfahan
Full name of responsible person
Dr Ali Kachoi
Street address
St Neshat 3rd floor of Javad alaema
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran Medical Sience University
Full name of responsible person
Dr MJ Hosseinzadeh
Street address
Enghelab sq,16 Azar st, Tehran
City
Tehran
Grant name
0
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Medical Sience University
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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Hajianfar
Position
MSc Student
Other areas of specialty/work
Street address
Enghelab sq, 16 Azar st, Tehran
City
Isfahan
Postal code
81438
Phone
+98 31 1951 3172
Fax
Email
hossein_hajian2005@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr MJ Hosseinzadeh
Position
MD&PhD
Other areas of specialty/work
Street address
Enghelab sq, 16 Azar st, Tehran
City
Tehran
Postal code
81438
Phone
+98 21 8895 1395
Fax
Email
mjh3a@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Hajianfar
Position
MSc Student
Other areas of specialty/work
Street address
No 11, complex Mahtab 8, Tayeb st.
City
Isfahan
Postal code
81438
Phone
+98 31 1951 3172
Fax
Email
hossein_hajian2005@yahoo.com
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
Loading...