Condition 1: Nonalcoholic fatty liver disease. Condition 2: Type 2 Diabetes. Condition 3: Cardiomyopathy. Nonalcoholic steatohepatitis (NASH) Type 2 diabetes Cardiomyopathy
Conditions
Interventions
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,
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 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%)
Exclusion criteria
Exclusion criteria: ??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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Echocardiographic Indices. Timepoint: At screening time (visit 1) and 24 weeks after the start of treatment (visit 7). Method of measurement: Echocardiograghy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFereshte Attaran
Iran University of Medical Sciences
Outcome results
None listed