Clinical Trial Details

Trial ID: L0853
Source ID: IRCT2016010411991N3
Associated Drug: Pioglitazone
Title: Compare the therapeutic effect of metformin, pioglitazone and vitaminE E in patients with non-alcoholic fatty liver disease
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: non-alcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
Interventions: Intervention 1: Intervention group: metformin2 gr daily,orally for12 weeks. Intervention 2: Intervention group: Pioglitazone30 mg dialy, orally for12 weeks. Intervention 3: Intervention group: vitamin E 800 IU daily, orally for 12 weeks.;Treatment - Drugs
Outcome Measures: Severity of fatty liver. Timepoint: before and 12 weeks after the interventions. Method of measurement: according to echogenicity of the liver and its comparison with the adjacent kidney, and also comparison with echogenicity of the spleen, and the view of diaphragm and perivascular region of the intrahepatic vessels.;Serum level of liver function tests (AST, ALT, Alkp). Timepoint: before and 12 weeks after the interventions. Method of measurement: (IU/l) by diagnostic laboratory kits (Pars Azmoon, Iran) and the auto analyzer (Hitachi 902).Body mass index(BMI). Timepoint: before and 12 weeks after the interventions. Method of measurement: (Kg/m2).;Insulin resistance index(HOMA-IR). Timepoint: before and 12 weeks after the interventions. Method of measurement: [fasting glucose (mg/dl) ?? insulin (??U/ml)]/ 405.;Fasting blood sugar. Timepoint: before and 12 weeks after the interventions. Method of measurement: mg/dlby diagnostic laboratory kits (Pars Azmoon, Iran) and the auto analyzer (Hitachi 902).;Serum level of insulin. Timepoint: before and 12 weeks after the interventions. Method of measurement: (??u/ml) by Monobind ELISA kit (Monobind, USA).
Sponsor/Collaborators: Vice chancellor for research,Kermanshah University of Medical Sciences
Gender: All
Age: 18 years75 years
Phases: Not applicable
Enrollment: 93
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
Start Date: 22/01/2016
Completion Date: --
Results First Posted: --
Last Update Posted: 22 February 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/12159