| Trial ID: | L0558 |
| Source ID: | IRCT2016102530489N1
|
| Associated Drug: |
Polyunsaturated Fatty Acids
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| Title: |
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.
|
| Acronym: |
--
|
| Status: |
Not Recruiting
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| 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: |
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.nan
|
| Sponsor/Collaborators: |
Yazd Shahid Sadoughi University of Medical Sciences
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| Gender: |
All
|
| Age: |
18 years60 years
|
| Phases: |
Phase 2/Phase 3
|
| Enrollment: |
60
|
| Study Type: |
interventional
|
| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
|
| Start Date: |
06/02/2017
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| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
22 February 2018
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/24210
|
