Protocol summary
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Study aim
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Evaluation of the effect of Omega 3 supplementation (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on lipid profile, and sestrin 2 and Nrf2 gene expression in patients with type 2 diabetes
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Design
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70 patients with type 2 diabetes 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.
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Settings and conduct
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This randomized double blind clinical trial is performed on 70 patients with type 2 diabetes admitted to Diabetes Clinic of Tehran University of Medical Sciences. Neither the patients nor the physician are aware of the type of supplement that is administered.
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 patients are given either 2700 mg n3PUFA in the form of oral capsules 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 measured.
Before and after intervention diet input, anthropometric characteristics, systolic and diastolic blood pressure are measured.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Drug group: treatment with n-3PUFA supplement, 2700 mg (combination of EPA=1800 mg and DHA=900 mg) for 10 weeks
Placebo group: treatment with oral paraffin for 10 weeks.
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Main outcome variables
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sestrin expression , NRF2 transcription factor gene expression
General information
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Reason for update
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Based on the calculations of sample size, the sample size that is stated in the "randomization section" (70 participants) is correct and the sample size 80 was entered mistakenly and must be corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150926024198N4
Registration date:
2018-01-28, 1396/11/08
Registration timing:
retrospective
Last update:
2020-01-30, 1398/11/10
Update count:
1
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Registration date
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2018-01-28, 1396/11/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Iran University of Medical Sciences
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Expected recruitment start date
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2016-07-22, 1395/05/01
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Expected recruitment end date
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2016-10-22, 1395/08/01
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Actual recruitment start date
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2015-08-22, 1394/05/31
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Actual recruitment end date
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2017-11-22, 1396/09/01
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Trial completion date
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2018-03-01, 1396/12/10
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Scientific title
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The effect of Omega 3 supplementation on oxidative stress & the gene expression of sestrin 2 enzyme & Nrf2 factor in diabetic patient type 2
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Public title
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The effect of Omega 3 supplementation on oxidative stress in patients with type 2 diabetes
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
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Age
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From 30 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
70
Actual sample size reached:
61
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be performed by permuted block randomization method using block of size 4. according to sample size which is 70, 18 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 will be used so that no one is informed about the type of intervention prior to selection.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-09-06, 1396/06/15
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Ethics committee reference number
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IR.IUMS.REC 1396.1213
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Sestrin gene expression
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Timepoint
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10 weeks
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Method of measurement
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Real time- polymerase chain reaction (PCR)
2
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Description
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NRF2 transcription factor gene expression
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Timepoint
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10 week
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Method of measurement
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Real-time PCR
3
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Description
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Serum total antioxidants
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Timepoint
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10 weeks
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Method of measurement
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spectrophotometry
Secondary outcomes
1
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Description
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Weight
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Timepoint
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10 weeks
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Method of measurement
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Scale
2
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Description
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BMI
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Timepoint
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10 weeks
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Method of measurement
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Calculation according to weight and height using relevant formula
3
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Description
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Insulin
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Timepoint
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10 weeks
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Method of measurement
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ELISA test
4
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Description
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A1C hemoglobin
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Timepoint
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10 weeks
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Method of measurement
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spectrophotometry
5
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Description
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Malondialdehyde
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Timepoint
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10 weeks
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Method of measurement
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colorimetry
6
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Description
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Fasting blood glucose
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Timepoint
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10 weeks
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Method of measurement
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colorimetry
7
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Description
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HOMA-IR
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Timepoint
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10 weeks
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Method of measurement
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calculation
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: oral paraffin for 10 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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96-02-30-31213
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All collected deidentified results from primary and secondary outcomes
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When the data will become available and for how long
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After publication of results
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To whom data/document is available
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Researchers from academic that applies
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Under which criteria data/document could be used
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For systematic analysis
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From where data/document is obtainable
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Contacting the person responsible for scientific enquieries
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What processes are involved for a request to access data/document
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two month
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Comments
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