Protocol summary

Summary
1- Objectives: Previous studies have shown that omega-3 fatty acids may reduce inflammation, oxidative stress, and fat mass in patients with type 2 diabetes, but the results are inconclusive, due, in part, to type of omega-3 fatty acids used. The aim of this study is to compare the effects of pure eicosapentaenoic and docosahexaenoic acids, the two major omega-3 fatty acids, on fat mass, oxidative stress, inflammation and blood sugar in patients with type 2 diabetes. 2- Design: double-blind placebo controlled trial 3- Setting and conduct: Sixty patients with type 2 diabetes will be referred from Institute of Endocrinology and Metabolism, Firouzgar Hospital, Tehran University of Medical Sciences. They will be randomly allocated to receive daily either 1 gram eicosapentaenoic or 1 gram docosahexaenoic acids, or a placebo for 12 weeks. Ten milliliters of fasting blood will be taken at baseline and at the end of the intervention. Serum malondialdehyde, C-reactive protein, fasting blood sugar and fat mass will be measured at baseline and after intervention. 4- Participants: 35-65 year-old patients with type 2 diabetes who are overweight and use oral hypoglycemic agent, Exclusion criteria: treatment with insulin; taking fish oil supplements or NSAIDs during the last 3 months before intervention; taking fish more than once a week; having cardiovascular, liver, kidney disease; smoking; weight changes more than three kilograms during three months before intervention; change in type or dose of oral hypoglycemic agent for at least two weeks prior to entry or during intervention; 5- Intervention: 1 gram eicosapentaenoic or docosahexaenoic acid daily , or placebo (canola oil) for 12 weeks 6- Main outcome measures variables: Serum malondialdehyde, C-reactive protein, fasting blood sugar and fat mass

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812102394N4
Registration date: 2011-06-06, 1390/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-06, 1390/03/16
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-06-01, 1389/03/11
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of ecosapentaenoic acid and docosahexaenoic acid on blood glucose, fat mass, MDA and C-reactive protein in patients with type 2 diabetes
Public title
Comparison of effects of EPA and DHA in patients with type 2 diabetes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 1- Age: 35-65years; 2- Willing to participate; 3- Having diabetes type 2 for at least five years prior to entry; 4- Blood sugar control with biguanide and sulfonylurea drugs for at least of one year prior to entry; 5- Normal blood pressure and lipid profile; 6- BMI : 20-35 kg/m2; Exclusion criteria: 1- Treatment with insulin; 2- Taking fish oil supplements or NSAIDs during the last 3 months before intervention; 3- Taking fish more than once a week; 4- Having cardiovascular, liver, kidney disease; 5- Smoking; 6- Weight changes more than three kilograms during three months before intervention; 7- Change in type or dose of oral hypoglycemic agent for at least two weeks prior to entry or during intervention;
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Approval date
2008-11-21, 1387/09/01
Ethics committee reference number
2399

Health conditions studied

1

Description of health condition studied
Diabetes Mellitus 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
at baseline, after 12 weeks
Method of measurement
enzymatic colorimetric

2

Description
fat mass
Timepoint
at baseline, after 12 weeks
Method of measurement
BIA

3

Description
malondialdehyde
Timepoint
at baseline, after 12 weeks
Method of measurement
ELISA

4

Description
C-reactive protein
Timepoint
at baseline, after 12 weeks
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
eicosapentaenoic acid: 1000 mg daily (four 250 mg soft gels) 2 times a day (at lunch time and dinner time) for 12 weeks
Category
Treatment - Other

2

Description
docosahexaenoic acid: 1000 mg daily (four 250 mg soft gels) 2 times a day (at lunch time and dinner time) for 12 weeks
Category
Treatment - Other

3

Description
Placebo : canola oil 1000 mg daily (four 250 mg soft gels) 2 times a day (at lunch time and dinner time) for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Institute of Endocrinology and Metabolism, Firouzgar Hospital
Full name of responsible person
Dr. Heidari
Street address
City
Teharn

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
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, Tehran 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
Assistant Professor, MD, PhD
Other areas of specialty/work
Street address
Department of Nutrition, School of public Health, Tehran University of Medical Sciences, #52, Alvand Street, Argantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
Sh_jazayeri@tums.ac.ir
Web page address

Person responsible for updating data

Contact

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...