| Trial ID: | L0233 |
| Source ID: | IRCT20190122042450N3
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| Associated Drug: |
Pioglitazone
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| Title: |
Comparison of the effect of empagliflozin and pioglitazone and placebo on liver steatosis change in fibroscan in diabetic patients with non-alcoholic fatty liver disease
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Condition 1: Nonalcoholic fatty liver disease. Condition 2: Diabetes type 2. <br>Nonalcoholic steatohepatitis [NASH] <br>Type 2 diabetes mellitus;K75.81
|
| Interventions: |
Intervention 1: Intervention group: Empagliflozin 10 milligram, Dr. Abidi pharmacy over 6 months. Intervention 2: Intervention group: Pioglitazone 15 milligram, Dr. Abidi pharmacy over 6 months. Intervention 3: Control group: placebo, Dr. Abidi pharmacy
|
| Outcome Measures: |
Change of CAP (Controlled attenuation parameter). Timepoint: at start and 24 weeks. Method of measurement: with fibroscan.Weight. Timepoint: start and 12 weeks and 24 weeks after intervention. Method of measurement: with weight scale.;Nonalcoholic fatty liver disease fibrosis score. Timepoint: start and 24 weeks after intervention. Method of measurement: with use of labroatary tests and formula of the NAFLD fibrosis score.;FIB4 index. Timepoint: start and 24 weeks after intervention. Method of measurement: with use of labroatary tests and formula of the FIB4.;A/G (Android/Gynoid). Timepoint: start and 24 weeks after intervention. Method of measurement: with Dual-energy X-ray absorptiometry (DEXA).;Liver stiffness measurement (LSM). Timepoint: start and 24 weeks after intervention. Method of measurement: Liver fibroscan.;VAT (Visceral adipose tissue). Timepoint: start and 24 weeks after intervention. Method of measurement: with Dual-energy X-ray absorptiometry (DEXA).;Body mass index. Timepoint: start and 12 weeks and 24 weeks after intervention. Method of measurement: with weight and height scale and formula.
|
| Sponsor/Collaborators: |
Iran University of Medical Sciences
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| Gender: |
All
|
| Age: |
20 years65 years
|
| Phases: |
Phase 2/Phase 3
|
| Enrollment: |
105
|
| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method, 6 blocks, Blinding description: Abidi's pharmacy place the empagliflozine and pioglitazon
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| Start Date: |
24/05/2019
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| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
26 August 2019
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| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/38419
|
