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IRCT20220910055934N1 IRCT 2022-11-01 Shahid Beheshti University of Medical Sciences Evaluation the effect of empagliflozin on diastolic function prediabetic people Evaluation of empagliflozin on diastolic function in prediabetic people with body mass index>30 kg/m2 Imam Hossein Hospital 2022-10-23 anticipated 39 Complete https://irct.ir/trial/66515 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The 4 random blocks are used. Each label has a letter A or B and the random sequence method is created using the website www.sealedenvelope.com using the random block method of 4 based on treatment group A or B for 38 (two groups of 19) patients, Blinding description: Empagliflozin drug of Actover Pharmaceutical Company (10 mg tablet in fasting form) and placebo (10 mg zinc sulfate tablet) with similar packaging, but different codes from the combination of numbers and letters A and B are used. Each patient is assigned a code at the beginning of the study, which is known by that code until the end of the study. This study is done as a three-way blind. In fact, both patients, doctors and laboratory personnel, outcome assessors and study data analysts are unaware of patient grouping. 3 Condition 1: Diastolic dysfunction. Condition 2: Obesity. Condition 3: pre-diabetic. Intervention 1: The intervention group will be treated with Empagliflozin 10 mg of Actover pharmaceutical company daily for 3 months. Cardiac function will be measured by Philips echocardiography device before and after 3 months of treatment. Blood sugar and blood lipid profile will be measured by an accredited laboratory, as well as blood pressure and BMI at these two times. Intervention 2: The control group will be treated with placebo daily for 3 months. Cardiac function will be measured by Philips echocardiography device before and after 3 months of treatment. Blood sugar and blood lipid profile will be measured by an accredited laboratory, as well as blood pressure and BMI at these two times. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: All researchers working in academic and scientific institutions, doctors and pharmaceutical companies will be allowed to access the information Conditions: The applicant can access the information after providing proof of identity. Where to obtain: Applicants can contact Dr. Reza Maleki at maleki330@yahoo.com to receive the desired documents or data How to obtain: The applicant can communicate with the researcher through e-mail and receive the basic data after presenting the identity documents Comments:
public Roxana Sadeghi
Shahid Madani University
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 roxan.sadeghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Roxana Sadeghi
Madani Street, Imam Hossein Hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 roxan.sadeghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) age more than 18 years old prediabetic (100<FBS<125) BMI more than 30 kg/m2 stability in cardiac symptom in the last 3 months 18 years no limit Both Using empagliflozin during the last 3 months I50.1 E66 Left ventricular failure Overweight and obesity Treatment - Drugs Placebo The intervention group will be treated with Empagliflozin 10 mg of Actover pharmaceutical company daily for 3 months. Cardiac function will be measured by Philips echocardiography device before and after 3 months of treatment. Blood sugar and blood lipid profile will be measured by an accredited laboratory, as well as blood pressure and BMI at these two times. The control group will be treated with placebo daily for 3 months. Cardiac function will be measured by Philips echocardiography device before and after 3 months of treatment. Blood sugar and blood lipid profile will be measured by an accredited laboratory, as well as blood pressure and BMI at these two times. The effect of empagliflozin in improving the E/e ratio after 3 months treatment. Timepoint: E/e dosing before the start of the study and after 3 months of continuous drug use. Method of measurement: Echocardiography. FBS. Timepoint: Before the intervention and 3 months after taking Empagliflozin. Method of measurement: Blood test. The effect of Empagliflozin on blood pressure. Timepoint: Blood pressure measurement before the start of the study and after 3 months of continuous use. Method of measurement: Pressure gauge device. The effect of empagliflozin on lowering blood sugar by measuring 2hpp. Timepoint: Blood sugar measurement using 2hpp before the intervention and 3 months after taking Empagliflozin. Method of measurement: blood test. The effect of empagliflozin on lowering blood sugar by measuring HbA1c. Timepoint: Blood sugar measurement using HbA1C before the intervention and 3 months after taking Empagliflozin. Method of measurement: blood test. Shahid Beheshti University of Medical Sciences Approved 2022-10-18 Ethic committee of Shahid Beheshti University of Medical Sciences Shahid Madani Street Tehran Tehran Iran (Islamic Republic of)