The effect of omega 3 polyunsaturated fatty acid supplementation on inflammatory markers and insulin resistanse factors in patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
This study is a double-blind placebo-controlled clinical trial. the aim of the study is to determine the effects of omega-3 supplementation on inflammatory markers and insulin resistanse factors in patients with type 2 diabetes and non-alcoholic fatty liver disease. 48 patients 18-60 years of age with diagnosed diabetes and non-alcoholic fatty liver disease. After filling out the consent, will be recruited to the study. Period of intervention is 12 weeks. According to random assignment, patients will be divided into two groups: 1) 2 gr/day of Omega-3 soft gels (Mercury free), or 2) 2 gr/day of edible paraffin soft gels (as placebo). Anthropometric and biochemical measurements, medical and general information and 24-hour dietary recalls will be collected at the beginning and end of the study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017103030489N2
Registration date:2017-11-16, 1396/08/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Zahra Orang
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
orang.zahra@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Health, Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega 3 polyunsaturated fatty acid supplementation on inflammatory markers and insulin resistanse factors in patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
Public title
The effect of omega 3 polyunsaturated fatty acid supplementation on inflammatory markers and insulin resistanse factors in patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include type II diabetes, nonalcoholic fatty liver disease, non-participation in the intervention program, ranging in age from 18 to 60 years, both men and women, not using insulin therapy, without any kidney; liver heart; thyroid, bleeding disorders or malignancies and lack of special diet Exclusion criteria from the study: type1 diabetes,alcoholic fatty liver disease, hepatitis type B and C, abuse alcohol, consume drugs and blood thinners such as warfarin, heparin or pentoxifylline, who recently had surgery, having allergic to seafood, uncontrolled high blood pressure, a weakened immune system and use drugs that cause fatty liver, such as steroids, estrogen, amiodarone, tamoxifen in the last 6 months
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
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
Department of Health, Yazd Shahid Sadoughi University of Medical Sciences
Street address
University Department, Alam square
City
Yazd
Postal code
Approval date
2017-01-31, 1395/11/12
Ethics committee reference number
IR.SSU.SPH.REC.1395.143
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
2
Description of health condition studied
Nonalcoholic fatty liver disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified (NAFLD)
Primary outcomes
1
Description
Fasting Insulin serum
Timepoint
baseline and after 12 weeks
Method of measurement
ELISA
2
Description
TNF-α
Timepoint
baseline and after 12 weeks
Method of measurement
ELISA
3
Description
IL-6
Timepoint
baseline and after 12 weeks
Method of measurement
ELISA
4
Description
hs-CRP
Timepoint
baseline and after 12 weeks
Method of measurement
By Laboratory Kit
5
Description
HOMA-IR
Timepoint
baseline and after 12 weeks
Method of measurement
Blood Sampling and putting glucose and insulin levels in formula
6
Description
HOMA-β
Timepoint
baseline and after 12 weeks
Method of measurement
Blood Sampling and putting glucose and insulin levels in formula
7
Description
QUICKI
Timepoint
baseline and after 12 weeks
Method of measurement
formula calculation
8
Description
Beta cell function
Timepoint
baseline and after 12 weeks
Method of measurement
HOMA2 calculator software
Secondary outcomes
empty
Intervention groups
1
Description
omega-3, 1 gr soft gel, twice a day for 12 weeks
Category
Placebo
2
Description
placebo capsule containing Paraffin food, 1 gr soft gel, twice a day for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Martyr Faghihi Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Hasan Mozaffari Khosravi (Director of Research in Shahid Sadugho university)
Street address
University Department, Alam square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi University 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zahra Orang
Position
Student of MSc Health Sciences in Nutrition
Other areas of specialty/work
Street address
University Department, Alam square
City
Yazd
Postal code
Phone
+98 353820910014
Fax
Email
orang.zahra@ssu.ac.ir/zahraorang72@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Position
PhD in Nutritional Sciences
Other areas of specialty/work
Street address
University Department, Alam square
City
Yazd
Postal code
Phone
+98 353820910014
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Zahra Orang
Position
Student of MSc Health Sciences in Nutrition
Other areas of specialty/work
Street address
City
Shiraz
Postal code
Phone
00
Fax
Email
orang.zahra@ssu.ac.ir/zahraorang72@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)