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IRCT20250524065869N1 IRCT 2025-06-09 Artesh University of Medical Sciences Comparison of high-dose and low-dose empagliflozin on fatty liver-related indices in patients with type 2 diabetes. Comparison of high-dose and low-dose empagliflozin on fatty liver-related indices in patients with type 2 diabetes. 2025-06-09 anticipated 56 Complete https://irct.ir/trial/83861 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method will be alternate allocation; patients will be assigned to the first and second groups alternately based on the time of their first visit day (coordination of the sequence of patient entry will be handled by the clinic secretary, who has no role in the study analysis). 3 Condition 1: Diabetes. Condition 2: Fatty Liver. Intervention 1: Intervention group: Patients with type 2 diabetes and NAFLD receiving empagliflozin 25 mg (high dose). This tablet is prescribed daily for 24 weeks. Intervention 2: Control group: Patients with type 2 diabetes and NAFLD receiving empagliflozin 10 mg (standard dose). This tablet is prescribed daily for 24 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Farshid Mollaghasem Shemirani
Shahid Chamran Hospital, Fakhrizadeh St., Langari St., Nobonyad
Tehran Iran (Islamic Republic of) 1693715814 +98 21 27956 farshidshemirani@yahoo.com Artesh University of Medical Sciences scientific Farshid Mollaghasem Shemirani
Shahid Chamran Hospital, Fakhrizadeh St., Langari St., Nobonyad
Tehran Iran (Islamic Republic of) 1693715814 +98 21 27956 farshidshemirani@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Age above 18 and below 80. History of diabetes, defined as HbA1c > 6.4. Ultrasound indicating of fatty liver. Mental health and alertness, with informed consent. Glomerular filtration rate (GFR) above 60. 18 years 80 years Both History of SGLT2 inhibitor use in the past 3 months. Contraindication to SGLT2 inhibitors, including recurrent urinary-genital infections and drug sensitivity. Secondary liver disease; including viral hepatitis, autoimmune hepatitis, and cholestasis. Cirrhosis or advanced liver disease. Use of corticosteroids, methotrexate, amiodarone, and other drugs that cause fatty liver. Alcohol addiction. Pregnant women. Failure to complete the follow-up period. Irregular use of empagliflozin. E11 K76.0 Type 2 diabetes mellitus Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Patients with type 2 diabetes and NAFLD receiving empagliflozin 25 mg (high dose). This tablet is prescribed daily for 24 weeks. Control group: Patients with type 2 diabetes and NAFLD receiving empagliflozin 10 mg (standard dose). This tablet is prescribed daily for 24 weeks. Framingham Steatosis Index (FSI): If the calculated number is greater than zero, the likelihood of fatty liver increases; on the other hand, if the result is negative, it weighs against the presence of fatty liver. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: History taking, Meter, Scale, Mercury blood pressure monitor and Standard laboratory. FIB-4: Non-invasive index for liver fibrosis. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: Standard laboratory. Triglyceride-glucose (TyG) Index: Indicates insulin resistance, a marker for fatty liver. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: Standard laboratory. Artesh University of Medical Sciences Approved 2025-05-06 Research Ethics Committees of AJA University of Medical Sciences AJAUMS ,Etemadzadeh St., West Fatemi St. Tehran Tehran Iran (Islamic Republic of)