Clinical Trial Details

Trial ID: L0520
Source ID: IRCT2017103030489N2
Associated Drug: Polyunsaturated Fatty Acids
Title: 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
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Condition 1: type 2 diabetes. Condition 2: Nonalcoholic fatty liver disease (NAFLD). <br>Non-insulin-dependent diabetes mellitus <br>Fatty (change of) liver, not elsewhere classified (NAFLD);Non-insulin-dependent diabetes mellitus;Fatty (change of) liver,
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;Placebo;omega-3, 1 gr soft gel, twice a day for 12 weeks;placebo capsule containin
Outcome Measures: 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-??. 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.nan
Sponsor/Collaborators: Yazd Shahid Sadoughi University of Medical Sciences
Gender: All
Age: 18 years60 years
Phases: Phase 2/Phase 3
Enrollment: 48
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
Start Date: 16/11/2017
Completion Date: --
Results First Posted: --
Last Update Posted: 22 February 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/24211