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IRCT20220902055858N1 IRCT 2022-09-24 Shahre-kord University of Medical Sciences Effect of Empagliflozin in Prediabetes A comparative analysis of effects of empagliflozin whit metformin on cardiometabolic factors and blood glucose of prediabetic patients 2022-09-23 anticipated 90 Complete https://irct.ir/trial/65691 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomized using random allocation software. In the software, the number of groups and the number of samples and the type of groups are determined. Then the numbers 1 to 90 are randomly assigned to three intervention groups. Group A, B and C; All three groups are subject to intervention, Blinding description: Participants will be divided into three intervention groups (A, B, C) using random allocation software. Then envelopes are prepared according to the number of people participating in the study and numbers 1 to 90 are written on the envelopes and placed in each envelope using A, B and C software. In this way, when each person enters, a special envelope is opened for that person and according to the option inside the envelope, the person is assigned to one of the three intervention groups. The patients are not aware of the group to which they belong until the end of the study. The intervention will be done by someone other than the researcher. 3 Condition 1: Impaired fasting glucose. Condition 2: Impaired glucose tolerance. Intervention 1: Intervention group: Prediabetic patients receiving metformin 500 mg twice a day ABIDI.Co for 3 months. Intervention 2: Intervention group: Prediabetic patients receiving empagliflozin 10 mg once a day َABIDI.Co for 3 months. Intervention 3: Intervention group: Prediabetic patients receiving empagliflozin 25 mg once a day َABIDI.Co for 3 months. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared. When: The access period starts 6 months after the results are published. To whom: Dr. Golshan Taghipur Conditions: After printing the data results can be used. Where to obtain: Data can be used by referring to e-mail. How to obtain: The access period starts 6 months after the results are published. Comments:
public Amin Moosavi
No.14, 3rd Andisheh Ave., Molasadra Blvd
Qazvin Iran (Islamic Republic of) 3415834937 +98 38 3365 8225 amin.moosavi@skums.ac.ir Shahre-kord University of Medical Sciences scientific Amin Moosavi
No.14, 3rd Andisheh Ave., Molasadra Blvd
Qazvin Iran (Islamic Republic of) 3415834937 +98 38 3365 8225 amin.moosavi@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Prediabetic Patient Age 17 to 65 years Not receiving blood sugar-lowering drugs 17 years 65 years Both Known case of Diabetes A history of urinary tract infection R73.01 R73.02 Impaired fasting glucose Impaired glucose tolerance (oral) Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Prediabetic patients receiving metformin 500 mg twice a day ABIDI.Co for 3 months Intervention group: Prediabetic patients receiving empagliflozin 10 mg once a day َABIDI.Co for 3 months Intervention group: Prediabetic patients receiving empagliflozin 25 mg once a day َABIDI.Co for 3 months Fasting blood sugar. Timepoint: Measurement of fasting blood sugar at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. Postprandial blood sugar. Timepoint: Measurement of Postprandial blood sugar at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. Glycosylated hemoglobin. Timepoint: Measurement of Glycosylated hemoglobin at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. Uric Acid level. Timepoint: Measurement of Uric Acid at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. C-Reactive Protein (CRP). Timepoint: Measurement of CRP at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. Cholesterol. Timepoint: Measurement of cholesterol at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. Low Density Lipoprotein (LDL). Timepoint: Measurement of LDL at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. High Density Lipoprotein (HDL). Timepoint: Measurement of HDL at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. Fasting Insulin Level. Timepoint: Measurement of Fasting Insulin Level at the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Peripheral blood biochemistry sample. Shahre-kord University of Medical Sciences Approved 2022-06-22 Ethics committee of Shahrekord University of Medical Sciences Hajar Hospital, Parastar Ave., Kashani Blvd., Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)