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IRCT20250919067293N1 IRCT 2025-09-29 Bagheiat-allah University of Medical Sciences Comparison of the effect of pioglitazone and Gloranta on metabolic factors of patients with non-alcoholic fatty liver disease and type 2 diabetes COEOPAG Comparison of the effect of pioglitazone and Gloranta on metabolic factors of patients with non-alcoholic fatty liver disease and type 2 diabetes 2025-10-17 anticipated 72 Complete https://irct.ir/trial/86266 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Blinding description: In this single-blind trial, the researchers involved in assessing the outcomes are unaware of the type of intervention that the patients receive. The study uses an independent person to collect the data who has no connection to the intervention, and after the data is collected, the results will be analyzed. 4 Condition 1: Diabetes mellitus. Condition 2: Non-alcoholic fatty liver. Intervention 1: Intervention group: Intervention group: 72 people with diabetes and non-alcoholic fatty liver disease were divided into two groups of 36 people: one group received pioglitazone 15 mg daily and the other group received 10.5 mg daily.The dose of Glurenta is 10.5 mg. An effective dose. Glurenta is administered orally once a day for 6 months. Then a blood sample is taken. Fasting blood glucose levels after 8 hours of fasting, blood levels of alanine aminotransferase (ALT), triglycerides (TG), free fatty acids (FFA) and CBC, ultrasound and cases requiring fibroscan are measured. Intervention 2: Intervention group: Intervention group: 72 patients with diabetes and non-alcoholic fatty liver disease were divided into two groups of 36 people: one group received pioglitazone 15 mg daily and the other group received 10.5 mg daily. After grouping, pioglitazone was administered orally once a day for 6 months.Then a blood sample is taken. Fasting blood glucose levels after 8 hours of fasting, blood levels of alanine aminotransferase (ALT), triglycerides (TG), free fatty acids (FFA), and CBC, and ultrasound and in cases requiring fibroscan are measured. 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 The project has not started yet.
public Fatemeh Bahrampour
Abuzar Street, Bad Akhshan Kamali Street, No. 24, Hakimian Alley
Tehran Iran (Islamic Republic of) 1363935191 +98 21 5517 3894 Nemesisgrace@googlemail.com Bagheiat-allah University of Medical Sciences scientific Fatemeh Bahrampour
Abuzar Street, Bad Akhshan Kamali Street, No. 24, Hakimian Alley
Tehran Iran (Islamic Republic of) 1363935191 +98 21 5517 3894 Nemesisgrace@googlemail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 75 years with non-alcoholic fatty liver disease and type 2 diabetes No history of alcohol consumption (20 grams per day for women and 30 grams per day for men) No history of cardiovascular events in the past 3 months Not pregnant or breastfeeding; active cancer or history of cancer treatment in the past 2 years; body mass index above 40 kg/m2. 18 years 75 years Both Active or chronic hepatitis; cirrhosis and biliary disease; heart failure, renal dysfunction (eGFR <45 ml/min/1.73 m2) during the study Taking medications associated with fatty liver nonsteroidal anti-inflammatory drugs (NSAIDs) (amiodarone, tamoxifen, sodium valproate, corticosteroids, methotrexate). Simultaneous use of both drugs, Glurenta and Empagliflozin E08 K76.0 Diabetes mellitus due to underlying condition Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: 72 people with diabetes and non-alcoholic fatty liver disease were divided into two groups of 36 people: one group received pioglitazone 15 mg daily and the other group received 10.5 mg daily.The dose of Glurenta is 10.5 mg. An effective dose. Glurenta is administered orally once a day for 6 months. Then a blood sample is taken. Fasting blood glucose levels after 8 hours of fasting, blood levels of alanine aminotransferase (ALT), triglycerides (TG), free fatty acids (FFA) and CBC, ultrasound and cases requiring fibroscan are measured. Intervention group: Intervention group: 72 patients with diabetes and non-alcoholic fatty liver disease were divided into two groups of 36 people: one group received pioglitazone 15 mg daily and the other group received 10.5 mg daily. After grouping, pioglitazone was administered orally once a day for 6 months.Then a blood sample is taken. Fasting blood glucose levels after 8 hours of fasting, blood levels of alanine aminotransferase (ALT), triglycerides (TG), free fatty acids (FFA), and CBC, and ultrasound and in cases requiring fibroscan are measured. Liver enzymes. Timepoint: Measurement of liver enzymes at the beginning of the study before the start of the intervention and 6 months after the start of Glurenta or pioglitazone. Method of measurement: A blood sample. Blood pressure. Timepoint: At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone. Method of measurement: Blood pressure measuring device. Body mass index of individuals. Timepoint: At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone. Method of measurement: Scales and meters. ، LDL، HDL، Total cholesterol,Triglycerides. Timepoint: At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone. Method of measurement: blood sample. Fatty liver. Timepoint: At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone. Method of measurement: The amount of liver fat is determined by ultrasound and fibroscan and based on the interpretation of the radiologist. (FBS، BS2hpp، Hba1c). Timepoint: At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone. Method of measurement: blood sample. Platelet. Timepoint: At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone. Method of measurement: blood sample. Bagheiat-allah University of Medical Sciences Approved 2025-08-06 Ethics Committee of Baqiyatullah University of Medical Sciences No. 24, Hakimian Alley, Badakhshan Kamali Street, Abuzar Street Tehran Tehran Iran (Islamic Republic of)