Evaluation of the effect of Omega 3 supplementation (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) on lipid profile, and sestrin 2 and Nrf2 factor gene expression in patients with type 2 diabetes
Design
80 patients with type 2 diabetes considering inclusion and exclusion criteria are divided into 2 groups of drug and placebo. The patients will be allocated randomly to either groups using permuted block randomization. Codes will be assigned to patients for concealment.
Settings and conduct
This randomized double blind clinical trial is performed on 80 patients with type 2 diabetes admitted to Diabetes Clinic of Tehran University of Medical Sciences. The study is designed as double blind trial and neither the patients not the physician are aware of the type of supplement that is administered. The clinical details of all the study subjects are recorded.
In the beginning of the study fasting blood samples are collected and used for the measurement of insulin , blood glucose, lipid profile. After the initial clinical and biochemical investigations all the diabetic patients are given either 2700 mg ω-3 fatty acids supplement in the form of oral capsules including EPA (1800 mg) and DHA (900 mg) per day or oral paraffin as the placebo in three divided doses for ten weeks. Blood samples are collected and all the above biochemical parameters including insulin, sestrin and NRF-2 gene expression and total antioxidant levels are meassured 10 weeks after intervention with omega 3 supplements.
Before and after intervention diet input, physical activity level, anthropometric characteristics, systolic and diastolic blood pressure are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having type 2 diabetes, BMI within 25-40 kg/m2 range, men 30-65 yr , women 30 yr-before menopause
Exclusion criteria: having other diseases, taking drugs which may affect obesity or metabolism, pregnancy and lactation.
Intervention groups
Drug group: treatment with n-3 PUFA supplement with the dose of 2700 mg (combination of EPA=1800 mg and DHA=900 mg) for 10 weeks
Placebo group: treatment with oral paraffin for 10 weeks.
The effect of Omega 3 supplementation on oxidative stress & the gene expression of sestrin 2 enzyme & Nrf2 factor in diabetic patient type 2
Public title
The effect of Omega 3 supplementation on oxidative stress in diabetic patient type 2
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with diabetes duration more than one year.
Diabetic patient in both genders, men 36-65 years old and women from 30 years old upto before menopause.
BMI in the range of 25-40 kg/m2.
Literateness (for recording 3-day meal)
Willingness to maintain weight during the study.
Willingness to maintain routine activities and current lifestyle during the study.
Willingness to participate in the study
Exclusion criteria:
pregnancy and lactation
Consumption of omega-3 supplement in the last three months.
having chronic renal, hepatic, enteric, haematic disorders, microalbuminuria, retinopathy, neuropathy, hypo/hyperthyroidism, cardiac disease, type 1 diabetes according to patient declaration and medical history.
Treatmetn with orlistat, cybotramin, insulin, thiazolidinediones, non-steroidical anti-inflammatory drugs
Using Combined oral contraceptive pills
Using dietary supplements, vitamin supplements, and herbal supplements at least 2 weeks before intervention
Changing dose or type of anti-diabetic drug
Occurrence of any inflammatory disease which requires using anti-inflammation drugs.
Unwillingness to continue participation.
Using less than 90 percent of the omega 3 supplement.
Appearance of any allergic reactions to omega-3.
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by permuted block randomization method using block of size 4. according to sample size which is 80, 20 blocks of 4 will be produced using www.sealedenvelope.com. In order to perform concealment, unique codes, produced by software, will be assigned to each participant and sealed pockets will be used so that no one is informed about the type of intervention prior to selection.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the patients are blinded. The placebo has been provided in a form similar to the main drug and each one is indicated by a code that only the main investigator is aware of. The patients do not know whether they are using the main drug or the placebo. The physician who is responsible for physical examination of the patient and administering the supplement is also blinded and not aware of the codes and only delivers the supplements to the patients. Data analyzer is also blinded and analyzes the data according to two separate groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-09-06, 1396/06/15
Ethics committee reference number
IR.IUMS.REC 1396.1213
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
sestrin expression
Timepoint
10 weeks
Method of measurement
Real time- polymerase chain reaction (PCR)
2
Description
NRF2 transcription factor gene expression
Timepoint
10 week
Method of measurement
Real-time PCR
3
Description
Serum total antioxidants
Timepoint
10 weeks
Method of measurement
spectrophotometry
Secondary outcomes
1
Description
weight
Timepoint
10 weeks
Method of measurement
kg-scale
2
Description
BMI
Timepoint
10 weeks
Method of measurement
kg/m2 - calculation according to weight and height
3
Description
insulin
Timepoint
10 weeks
Method of measurement
IU/mlm -elisa
4
Description
A1C hemoglobin
Timepoint
10 weeks
Method of measurement
spectrophotometry
Intervention groups
1
Description
Intervention with omega 3 polyunsaturated fatty acid supplement by the daily dose of 1250 mg (combination of EPA=600 mg and DHA= 300 mg) for 10 weeks.
Category
Treatment - Drugs
2
Description
Control group: oral paraffin for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Mazaherion
Street address
North Kargar, Shahrivar st.
City
tehran
Province
Tehran
Postal code
1411715851
Phone
+98 21 8833 4192
Email
maryammazaherioon@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
+98 21 8862 2742
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
96-02-30-31213
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mazaherioon
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No162, between vatan poor and aghaee Ave,West Farmanieh
City
Tehran
Province
Tehran
Postal code
1984614456
Phone
+98 21 2665 7890
Email
maryammazaherioon@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Nourbakhsh
Position
Assistant profesoor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry Department, Faculty of Medicine, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 3109
Fax
+98 21 8862 2742
Email
nourbakhsh.m@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Nourbakhsh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry department, Faculty of Medicine, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 3109
Fax
+98 21 8862 2742
Email
nourbakhsh.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All collected deidentified results from primary and secondary outcomes
When the data will become available and for how long
After publication of results
To whom data/document is available
Researchers from academic that applies
Under which criteria data/document could be used
For systematic analysis
From where data/document is obtainable
Contacting the person responsible for scientific enquieries
What processes are involved for a request to access data/document