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IRCT20150926024198N4 IRCT 2018-01-28 Iran University of Medical Sciences The effect of Omega 3 supplementation on oxidative stress in patients with type 2 diabetes The effect of Omega 3 supplementation on oxidative stress & the gene expression of sestrin 2 enzyme & Nrf2 factor in diabetic patient type 2 2016-07-22 anticipated 70 Complete https://irct.ir/trial/20486 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, 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. 3 Type 2 diabetes. Intervention 1: 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. Intervention 2: Control group: oral paraffin for 10 weeks. Yes - There is a plan to make this available What will be shared: All collected deidentified results from primary and secondary outcomes When: After publication of results To whom: Researchers from academic that applies Conditions: For systematic analysis Where to obtain: Contacting the person responsible for scientific enquieries How to obtain: two month Comments:
public Maryam Mazaherioon
No162, between vatan poor and aghaee Ave,West Farmanieh
Tehran Iran (Islamic Republic of) 1984614456 +98 21 2665 7890 maryammazaherioon@yahoo.com Tehran University of Medical Sciences scientific Mitra Nourbakhsh
Biochemistry Department, Faculty of Medicine, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 3109 nourbakhsh.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 30 years 65 years Both 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. E11 Type 2 diabetes mellitus Treatment - Drugs Placebo 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. Control group: oral paraffin for 10 weeks Sestrin gene expression. Timepoint: 10 weeks. Method of measurement: Real time- polymerase chain reaction (PCR). NRF2 transcription factor gene expression. Timepoint: 10 week. Method of measurement: Real-time PCR. Serum total antioxidants. Timepoint: 10 weeks. Method of measurement: spectrophotometry. Weight. Timepoint: 10 weeks. Method of measurement: Scale. BMI. Timepoint: 10 weeks. Method of measurement: Calculation according to weight and height using relevant formula. Insulin. Timepoint: 10 weeks. Method of measurement: ELISA test. A1C hemoglobin. Timepoint: 10 weeks. Method of measurement: spectrophotometry. Malondialdehyde. Timepoint: 10 weeks. Method of measurement: colorimetry. Fasting blood glucose. Timepoint: 10 weeks. Method of measurement: colorimetry. HOMA-IR. Timepoint: 10 weeks. Method of measurement: calculation. Iran University of Medical Sciences Approved 2017-09-06 Ethics committee of Iran University of Medical Sciences Hemmat Highway Tehran Tehran Iran (Islamic Republic of)