The effect of omega 3 polyunsaturated fatty acid supplementation on inflammatory markers and insulin resistanse factors in patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017103030489N2

Enrollment

Registered

2017-11-16

Start date

2016-12-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: type 2 diabetes. Condition 2: Nonalcoholic fatty liver disease (NAFLD). Non-insulin-dependent diabetes mellitus Fatty (change of) liver, not elsewhere classified (NAFLD)

Interventions

Intervention 1: omega-3, 1 gr soft gel, twice a day for 12 weeks. Intervention 2: placebo capsule containing Paraffin food, 1 gr soft gel, twice a day for 12 weeks.

Placebo

omega-3, 1 gr soft gel, twice a day for 12 weeks

placebo capsule containing Paraffin food, 1 gr soft gel, twice a day for 12 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria include type II diabetes, nonalcoholic fatty liver disease, non-participation in the intervention program, ranging in age from 18 to 60 years, both men and women, not using insulin therapy, without any kidney; liver heart; thyroid, bleeding disorders or malignancies and lack of special diet Exclusion criteria from the study: type1 diabetes,alcoholic fatty liver disease, hepatitis type B and C, abuse alcohol, consume drugs and blood thinners such as warfarin, heparin or pentoxifylline, who recently had surgery, having allergic to seafood, uncontrolled high blood pressure, a weakened immune system and use drugs that cause fatty liver, such as steroids, estrogen, amiodarone, tamoxifen in the last 6 months

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Fasting Insulin serum. Timepoint: baseline and after 12 weeks. Method of measurement: ELISA.;TNF-a. Timepoint: baseline and after 12 weeks. Method of measurement: ELISA.;IL-6. Timepoint: baseline and after 12 weeks. Method of measurement: ELISA.;Hs-CRP. Timepoint: baseline and after 12 weeks. Method of measurement: By Laboratory Kit.;HOMA-IR. Timepoint: baseline and after 12 weeks. Method of measurement: Blood Sampling and putting glucose and insulin levels in formula.;HOMA-ß. Timepoint: baseline and after 12 weeks. Method of measurement: Blood Sampling and putting glucose and insulin levels in formula.;QUICKI. Timepoint: baseline and after 12 weeks. Method of measurement: formula calculation.;Beta cell function. Timepoint: baseline and after 12 weeks. Method of measurement: HOMA2 calculator software.	—

Measure

Time frame

Fasting Insulin serum. Timepoint: baseline and after 12 weeks. Method of measurement: ELISA.;TNF-a. Timepoint: baseline and after 12 weeks. Method of measurement: ELISA.;IL-6. Timepoint: baseline and after 12 weeks. Method of measurement: ELISA.;Hs-CRP. Timepoint: baseline and after 12 weeks. Method of measurement: By Laboratory Kit.;HOMA-IR. Timepoint: baseline and after 12 weeks. Method of measurement: Blood Sampling and putting glucose and insulin levels in formula.;HOMA-ß. Timepoint: baseline and after 12 weeks. Method of measurement: Blood Sampling and putting glucose and insulin levels in formula.;QUICKI. Timepoint: baseline and after 12 weeks. Method of measurement: formula calculation.;Beta cell function. Timepoint: baseline and after 12 weeks. Method of measurement: HOMA2 calculator software.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Orang

Yazd Shahid Sadoughi University of Medical Sciences

orang.zahra@ssu.ac.ir/zahraorang72@gmail.com+98 353820910014

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026