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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150926024198N4
Enrollment
70
Registered
2018-01-28
Start date
2016-07-22
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes. Type 2 diabetes mellitus

Interventions

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: or

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Mazaherioon

Tehran University of Medical Sciences

maryammazaherioon@yahoo.com+98 21 2665 7890

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 28, 2026