Effect of omega-3 fatty acid supplementation in patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease.

The effect of omega 3 polyunsaturated fatty acid supplementation on Glycemic indicators, Lipid profile and liver function 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

IRCT2016102530489N1

Enrollment

Registered

2017-02-06

Start date

2016-08-22

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
HbA1c. Timepoint: baseline and after 12 weeks. Method of measurement: ELISA.;FBS. Timepoint: baseline and after 12 weeks. Method of measurement: enzymatic.;ALT. Timepoint: baseline and after 12 weeks. Method of measurement: photometric assay.;AST. Timepoint: baseline and after 12 weeks. Method of measurement: photometric assay.;GGT. Timepoint: baseline and after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;Serum Triglycerides. Timepoint: baseline and after 12 weeks. Method of measurement: enzymatic.;Total Cholesterol. Timepoint: baseline and after 12 weeks. Method of measurement: enzymatic.;HDL- Cholesterol. Timepoint: baseline and after 12 weeks. Method of measurement: enzymatic.;LDL-Cholesterol. Timepoint: baseline and after 12 weeks. Method of measurement: Friedewald formula.	—

Measure

Time frame

HbA1c. Timepoint: baseline and after 12 weeks. Method of measurement: ELISA.;FBS. Timepoint: baseline and after 12 weeks. Method of measurement: enzymatic.;ALT. Timepoint: baseline and after 12 weeks. Method of measurement: photometric assay.;AST. Timepoint: baseline and after 12 weeks. Method of measurement: photometric assay.;GGT. Timepoint: baseline and after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;Serum Triglycerides. Timepoint: baseline and after 12 weeks. Method of measurement: enzymatic.;Total Cholesterol. Timepoint: baseline and after 12 weeks. Method of measurement: enzymatic.;HDL- Cholesterol. Timepoint: baseline and after 12 weeks. Method of measurement: enzymatic.;LDL-Cholesterol. Timepoint: baseline and after 12 weeks. Method of measurement: Friedewald formula.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Orang

Yazd Shahid Sadoughi University of Medical Sciences

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

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 22, 2026