| Trial ID: | L0435 |
| Source ID: | IRCT20200128046294N1
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| Associated Drug: |
Empagliflozin
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| Title: |
A Prospective Randomized Controlled Trial Comparing Three Advanced Therapies in the Treatment of Non-Alcoholic Steatohepatitis
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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: Nonalcoholic Steatohepatits (NASH). Condition 2: Obesity. <br>Nonalcoholic steatohepatitis (NASH) <br>Overweight and obesity;K75.81
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| Interventions: |
Intervention 1: Intervention group 1: Sleeve Gastrectomy - During laparoscopic SG, gastric resection starts within 3 to 6 cm of the pylorus along the greater curvature of stomach and ends with removal of the fundus, calibrated using a bougie. Intervention
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| Outcome Measures: |
Liver Histopathology. Timepoint: before intervention and 12 months after intervention. Method of measurement: NAFLD activity score + hepatocellular ballooning + Fibrosis stage.Liver Enzyme Activity. Timepoint: Before intervention and 6, 12 months after intervention. Method of measurement: Blood Test (ALT , AST , ALK.Phosphatase , Bilirubin).;Anthropometric changes. Timepoint: Before intervention and 1, 3, 6, 9, 12 months after intervention. Method of measurement: Waist Circumference + Weight and BMI.;Metabolic Changes. Timepoint: Before intervention and 12 months after intervention. Method of measurement: Lab Lipid Profile (Chol, LDL, HDL, TG) + Blood Pressure (sphygmomonometer) + Lab (BS, HbA1C, HOMA-IR) + CRP.;Quality of Life. Timepoint: Before intervention and 6, 12 months after intervention. Method of measurement: SF-36 questionnaire + chronic liver disease questionnaire (CLDQ) for NASH (CLDQ-NASH).;Complications. Timepoint: 1, 3, 6, 9, 12 months after intervention. Method of measurement: Complications specifically related to NASH disease, as well as complications of liver biopsy, liraglutide, empagliflozin, and SG will be recorded and evaluated through history taking and physical examination.;Liver stiffness. Timepoint: before intervention and 12 months after intervention. Method of measurement: Fibroscan Score.
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| Sponsor/Collaborators: |
Dr. Abidi Pharmaceuticals
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| Gender: |
All
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| Age: |
18 years65 years
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| Phases: |
Phase 3
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| Enrollment: |
105
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized in a 1:1:1 ratio into one of the three treatment groups using computer generated rando
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| Start Date: |
22/02/2020
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
21 June 2021
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| Locations: |
Iran (Islamic Republic of);Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/45518
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