The effect of Omega 3 supplementation on oxidative stress in patients with type 2 diabetes

Phase 3

Conditions: Type 2 diabetes.
Type 2 diabetes mellitus

Registration Number: IRCT20150926024198N4

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 70

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.