Trial ID: | L0520 |
Source ID: | IRCT2017103030489N2
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Associated Drug: |
Polyunsaturated Fatty Acids
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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
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Acronym: |
--
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Status: |
Not Recruiting
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Study Results: |
No Results Available
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Results: |
--
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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,
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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
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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
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Sponsor/Collaborators: |
Yazd Shahid Sadoughi University of Medical Sciences
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Gender: |
All
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Age: |
18 years60 years
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Phases: |
Phase 2/Phase 3
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Enrollment: |
48
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Study Type: |
interventional
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Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
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Start Date: |
16/11/2017
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Completion Date: |
--
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Results First Posted: |
--
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Last Update Posted: |
22 February 2018
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Locations: |
Iran (Islamic Republic of)
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URL: |
http://en.irct.ir/trial/24211
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