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IRCT20230724058910N1 IRCT 2023-08-07 Zanjan University of Medical Sciences To Study the effect of Empagliflozin on the cardiovascular biomarkers in diabetic patients myocardial infarction To Study the effect of Empagliflozin on the cardiovascular biomarkers Galectin-3 and sST-2 in type 2 diabetic patients myocardial infarction with requiring primary angioplasty 2023-08-23 anticipated 60 Complete https://irct.ir/trial/71601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: By coding the third person (collaborator), drug and placebo are divided into odd and even groups. With the random allocation rule method, a set of 30 even codes and 30 odd codes are placed in a lottery container, and the codes are randomly removed from the container without replacement, and the created sequence is recorded, and the medicine is given to the patients based on that, Blinding description: The study will be conducted as a double-blind clinical trial. In this study, the researcher, the patient and the healthcare personnel do not know whether the patient is being treated with medicine or placebo. By coding the third person (collaborator), the drug and placebo are divided into two groups and given to the patients randomly. 4 Condition 1: Myocardial Infarction. Condition 2: Type 2 diabetes. Intervention 1: Intervention group: In this group, 30 type 2 diabetic patients treated with oral drugs, and they will receive empagliflozin from ABIDI Pharmaceutical Company in the form of 10 mg tablets, once a day orally for 3 months. Intervention 2: Control group: In this group, 30 type 2 diabetic patients treated with oral drugs, and they will receive placebo made by ABIDI Pharmaceutical Company, once a day orally for 3 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 isn't further information.
public Mahnaz Yousefi Ramandi
Gavazang road, Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 912 883 3831 mahnaz.yousefi@gmail.com Zanjan University of Medical Sciences scientific Reza Madadi
Gavazang road, Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 912 542 6122 R_madady2000@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetic patients (Hb A1C: 6.5-8) Diabetes treated with oral agents Typical chest pain during the 12 hours before presentation lasting more than 30 minutes ST- segment elevation above 0.1 mV in two leads or more in ECG no limit no limit Both Cardiogenic shock Diabetic ketoacidosis History of CABG Type 1 diabetic patients Severe liver failure End stages cancer or history of any cancer History of severe allergy to empagliflozin or its formulation components Severe renal failure (eGFR <30 mL/minute/1.73 m2), end-stage renal disease (ESRD), or dialysis Hypovolemia Any inflammatory disease under treatment Advanced heart failure Hypoglycemia I21.3 E11.9 Acute transmural myocardial infarction of unspecified site Type 2 diabetes mellitus without complications Treatment - Drugs Placebo Intervention group: In this group, 30 type 2 diabetic patients treated with oral drugs, and they will receive empagliflozin from ABIDI Pharmaceutical Company in the form of 10 mg tablets, once a day orally for 3 months. Control group: In this group, 30 type 2 diabetic patients treated with oral drugs, and they will receive placebo made by ABIDI Pharmaceutical Company, once a day orally for 3 months. Galectin-3 gene expression. Timepoint: Measurement of Galectin-3 gene expression at the beginning of the study (before intervention) and 3 months after starting empagliflozin. Method of measurement: RT-PCR. SST2 gene expression. Timepoint: Measurement of sST2 gene expression at the beginning of the study (before intervention) and 3 months after starting empagliflozin. Method of measurement: RT-PCR. Abidi Pharmaceutical Company Zanjan University of Medical Sciences Abidi Pharmaceutical Company Approved 2023-07-04 Ethics committee of Zanjan University of Medical Siences Professor Youssef Sobouti Blvd., Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)