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IRCT20130610013612N12 IRCT 2022-09-12 Tabriz University of Medical Sciences Evaluation of the effect of Empagliflozin on blood glucose, BMI, HbA1c and insulin dose in patients with type 1 diabetes Evaluation of the effect of Empagliflozin on blood glucose, BMI, HbA1c and insulin dose in patients with type 1 diabetes 2022-08-22 anticipated 60 Complete https://irct.ir/trial/65540 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stratified permuted block randomization will be applied to stratify participants into different stratum and blocks based on gender and probable confounders. Each block will be randomly allocated to the intervention or control groups. The sequence of the blocks will be prepared for each stratum Random Allocation Software (RAS). For each patient in a definite block, a matched person in terms of the aforementioned variables would be considered in that block. Participants and investigators will be blind to the trial group assignments until the end of the study and data analysis, Blinding description: In this study, the main investigator and patients will be blind (empagliflozin or placebo) . The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three digit code to each of the two (empagliflozin and placebo), and keep the codes for himself until the end of the study and data analyses. N/A Diabetes type 1. Intervention 1: Control group: the control group individuals will receive starch tablets which are completely identical in appearance to the supplement and will receive daily for 3 months. Intervention 2: Intervention group: The supplement group will take one empagliflozin tablet (10 mg) made by Varian Farmed company for 12 weeks. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Access starting 12 months after publication To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta-analysis. Where to obtain: The researchers (student and her supervisor) How to obtain: Request a document via email Comments:
public Farzad Najafipour
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 8939 najafipourf@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Farzad Najafipour
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 8939 najafipourf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Type 1 diabetes Age over 18 years and less than 30 years Able to measure blood sugar daily Be able to measure daily urine ketones HbA1C between 7.5% - 8.5% 18 years 30 years Both Kidney failure Active infection urinary infection pregnancy Cortone use E10 Type 1 diabetes mellitus Placebo Treatment - Drugs Control group: the control group individuals will receive starch tablets which are completely identical in appearance to the supplement and will receive daily for 3 months. Intervention group: The supplement group will take one empagliflozin tablet (10 mg) made by Varian Farmed company for 12 weeks. Hemoglobin A1c. Timepoint: Baseline and 3 months after the treatment. Method of measurement: Electrochemiluminescence Test. Fasting Blood Sugar. Timepoint: Baseline and 3 months after the treatment. Method of measurement: Electrochemiluminescence Test. 2 hour Post Prandial. Timepoint: Baseline and 3 months after the treatment. Method of measurement: Electrochemiluminescence Test. Body Mass Index. Timepoint: Baseline and 3 months after the treatment. Method of measurement: weight scale and stadiometer. Tabriz University of Medical Sciences Approved 2022-08-21 Ethics Committee Tabriz University of Medical Sciences Ethics Committee,Tabriz University of Medical Sciences, Golgasht Street , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)