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IRCT20190122042450N5 IRCT 2020-11-29 Iran University of Medical Sciences The cardiac effect of pioglitazone and empagliflozin among diabetic patients with NAFLD A Comparison between the Effect of Empagliflozin and Pioglitazon on Echocardiographic Indices in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease 2020-10-22 anticipated 70 Complete https://irct.ir/trial/50993 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be randomized by random blocking method with quadruple blocks and using a random number table of random allocation software .Blocking and allocation sequencing for concealment will be done by the non-research person, Blinding description: Abidi's pharmaceutical company produces the empagliflozine and pioglitazone in the same package and labels them as A and B, distributes between patients by non-notified person while patient and investigator are also not informed about type of the drugs. Also, health-care and staffs of laboratory and fibroscan and echocardiography are not informed about type of drugs. Also, outcome evaluator and data analyzer are not informed about type of drugs used by each group. 2 Condition 1: Nonalcoholic fatty liver disease. Condition 2: Type 2 Diabetes. Condition 3: Cardiomyopathy. Intervention 1: Intervention group 1: Empagliflozin 10 milligram, produced by Dr.Abidi pharmaceutical company, once daily for 6 months. Intervention 2: Intervention group 2: Pioglitazone 30 milligram, once daily, produced by Dr.Abidi pharmaceutical company, for 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 Data will be published, if necessary, at the end of the study.
public Fereshte Attaran
Institute of adult endocrinology and metabolism; Firooze alley; Karimkhan avenue; Vali-asr square
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8894 5246 Fereshte1Attaran@gmail.com Iran University of Medical Sciences scientific Mohammad Ebrahim Khamseh
Institute of adult endocrinology and metabolism; Firooze alley; Karimkhan avenue; Vali-asr square
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8894 5246 khamseh.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetes mellitus (T2DM) HbA1C between 7-10.5% Non-alcoholic fatty liver disease (NAFLD) with cap score >302 dB/m Normal Ejection Fraction (EF≥50%) 20 years no limit Both ََArrhythmia Ischemic or non Ischemic heart disease Peripheral artery disease Current use of SGLT2 inhibitors Current use of Glucagone like peptide 1 receptor agonist Current use of Thiazolidendions Current use of Tamoxifen Current use of Amiodarone Current use of Nonsteroid anti inflammatory agents Current use of Vitamin C Current use of Vitamin E Current use of Selenium Current use of other antioxidants Pregnancy Breast feeding Hypothyroidism Hyperthyroidism Cirrhosis Hepatitis B Hepatitis C Autoimmune Hepatitis Any form of chronic liver disease except fatty liver disease Alcohol consumption more than 30 gr/day in men Alcohol consumption more than 20 gr/day in women eGFR<45 cc/min/1.73 m2 Corticosteroid use at least 14 days in the past month Active cancer History of the treated cancer in the past 2 years. Current use of fibrates K75.81 E11 I42 Nonalcoholic steatohepatitis (NASH) Type 2 diabetes Cardiomyopathy Treatment - Drugs Treatment - Drugs Intervention group 1: Empagliflozin 10 milligram, produced by Dr.Abidi pharmaceutical company, once daily for 6 months. Intervention group 2: Pioglitazone 30 milligram, once daily, produced by Dr.Abidi pharmaceutical company, for 6 months Echocardiographic Indices. Timepoint: At screening time (visit 1) and 24 weeks after the start of treatment (visit 7). Method of measurement: Echocardiograghy. Weight. Timepoint: At start ,after 12 weeks and 24 weeks. Method of measurement: weight scale. Body mass index (BMI). Timepoint: At start ,after 12 weeks and 24 weeks. Method of measurement: Calculation with formula. Liver stiffness measurement (LSM). Timepoint: At start and 24 weeks after intervention. Method of measurement: Liver fibroscan. Nonalcoholic fatty liver disease fibrosis score. Timepoint: At start and 24 weeks after intervention. Method of measurement: By use of labroatary tests and formula of the NAFLD fibrosis score. FIB4 index. Timepoint: At start and 24 weeks after intervention. Method of measurement: By use of laboratory tests and formula of the FIB4. The change of CAP (Controlled attenuation parameter). Timepoint: At start and 24 weeks. Method of measurement: By liver fibroscan. Iran University of Medical Sciences Approved 2020-03-18 Ethics committee of Iran University of Medical Sciences Shahid Hemmat highway Tehran Tehran Iran (Islamic Republic of)