]>
IRCT20190122042450N3 IRCT 2019-05-24 Iran University of Medical Sciences The effect of empagliflozin on nonalcoholic fatty liver disease in diabetic patients 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 2019-05-21 anticipated 105 Complete https://irct.ir/trial/38419 interventional 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 pioglitazone and placebo in unique package and label as Q, M, Z and distribute between patients by non-notofied person while patient and investigator are not informed about type of drugs. Also, health-care and staffs of labroatory and radiology and fibroscan and DEXA are not informed about type of drugs. Also, Outcome evaluator and data analyzer are not informed about type of drugs. 2-3 Condition 1: Nonalcoholic fatty liver disease. Condition 2: Diabetes type 2. 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 over 6 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is not sufficient data.
public Haleh Chehrehgosha
Behafarin ST, Karimkhan AVE, Vali-asr Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8894 5246 hchehrehgosha@gmail.com Iran University of Medical Sciences scientific Mohammad Ebrahim Khamseh
Behafarin ST, KarimkhanAVE, Vali-asr Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8894 5246 khamseh.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age 20-65 Body mass index less than 40 Alcohol daily consumption less than 20 g in women and less than 30 g in men, for at least 3 consecutive months over 5 years ago Hemoglobin A1c 7-10 percent Alanin aminotransferase more than 45 in men and more than 30 in women Creatinin less than 1.5 in men and less than 1.4 in women and glomerular filtration rate more than 45 Controlled atenuated parameter more than 230 in fibroscan or fatty liver grade equal and more than 2 in liver sonography Signature of consent form 20 years 65 years Both Pregnancy, breast feeding Heart failure (class II to IV) History of cardiovascular disease in 3 months ago History of cancer in 2 years ago History of cirrhosis Abnormal TSH (uncontrolled yper or hypothyroidism) Autoimmune hepatitis (abnormal ANA and ASMA) Hepatitis C (positive HCV Ab) Hepatitis B (positive HBS Ag) Consumption of NSAIDs, Amiodarone, Tamoxifen, Fibrate, statin, Zinc, Selenium and vitamin C or other antioxidant drugs, Empagliflozin, Metformin, Pioglitazone, Vitamin E and other fatty liver drugs. Diabetes type 1 or secondary diabetes Consumption of corticosteroid for 14 days over 2 months ago biliary obstruction in liver and gallbladder sonography K75.81 E11 Nonalcoholic steatohepatitis [NASH] Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Placebo Intervention group: Empagliflozin 10 milligram, Dr. Abidi pharmacy over 6 months Intervention group: Pioglitazone 15 milligram, Dr. Abidi pharmacy over 6 months Control group: placebo, Dr. Abidi pharmacy over 6 months 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. Abidi pharmacy Iran University of Medical Sciences Abidi pharmacy Approved 2019-03-10 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)