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IRCT20210906052395N1 IRCT 2022-03-16 Shahid Beheshti University of Medical Sciences Effect of Empagliflozin in diabetic nephropathy Assessment of Empagliflozin effect on renal outcome in patients with type 2 diabetes mellitus 2021-09-23 anticipated 96 Complete https://irct.ir/trial/58606 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Number of 96 patients with diabetic nephropathy(GFR<60 or albuminuria>300)and inclusion criteria are selected then randomization is done by block method ( Block stratified randomization). So that first all 4 blocks which include two codes A and B(drug and placebo) are prepared (4 non identical block arrangements and a total of 24 blocks) then random tables of random blocks are selected using placement. These blocks form a sample-sized sequence of codes A and B, each of which is randomly and confidentially and without considering the patients conditions ,is given to the doctor by the clinic secretary for prescription to the patient. The list of relevant codes will remain with the clinic secretary until the completion of the project. This method will provide both blinding and randomization, Blinding description: Participating patients were randomized by block method ( block stratified randomization ) and patients before entering the study would be informed and satisfied that in addition to the main treatment of glycemic control(metformin and /or insulin),accidentally and without their knowledge of the type of drug, will receive empagliflozin or placebo. Placebo and Empagliflozin would be designed identical and would be packed unanimously in identical boxes so patients in both groups will not be informed of their medication. One of the research team members would dedicate either placebo or Empagliflozin to patients(The first blinding step). Also, the researcher (physician) and the person who followed the patient's symptoms and conditions for months and records them, does not know the type of drug prescribed (A or B)(The second blinding step). 3 Nephropathy and proteinuria in diabetic nephropathy patients taking empagliflozin. Intervention 1: Intervention group: Receive 10 mg Empagliflozin tablets (Gloripa brand, Abidi Pharmaceutical Company,) one daily for 48 weeks in addition to the previous standard treatment(metformin and/or insulin). Intervention 2: Control group: Receive placebo tablets one daily for 48 weeks in addition to the previous standard treatment(metformin and/or insulin). Yes - There is a plan to make this available What will be shared: At the end of the study and after the results are published, information about the study protocol, how to analyze the data, and the main outcomes are shared. When: 6 months after publishing the results To whom: Researchers working in academia and in the drug industries Conditions: Any analysis and use of the data and documentation submitted will be conditional with informing project executor and her consent. Where to obtain: Refer to Dr.Almas khatami zenozian, principal Executor, for the documentation. Email: almaskhatami@gmail.com Affiliations: Faculty of Medicine ,Shahid Beheshti University of Medical Sciences How to obtain: The applicant should send an application to Dr.Almas khatami zenozian by email and she will respond as soon as possible after reviewing and consulting with other project members Comments:
public Almas khatami zenozian
Shahid Madani Ave,Imam Hosein hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 Almaskhatami@gmail.com Shahid Beheshti University of Medical Sciences scientific Shayesteh khalili
Shahid Madani Ave,Imam Hoseine hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 almaskhatami@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patient with type2 diabetes over the age of 18 years GFR<60 or albuminuria 18 years no limit Both Recent myocatdial infarction and PCI Dialysis in the last ninety days GFR<30 Renal failure for reasons other than diabetes Recurrent urinary tract infections History of amputation due to diabetes Bladder cancer Active diabetic foot ulcer type 1 diabetes Pregnancy and lactation Major surgery performed in the last 28 days E08.21 Diabetes mellitus due to underlying condition with diabetic nephropathy Treatment - Drugs Placebo Intervention group: Receive 10 mg Empagliflozin tablets (Gloripa brand, Abidi Pharmaceutical Company,) one daily for 48 weeks in addition to the previous standard treatment(metformin and/or insulin) Control group: Receive placebo tablets one daily for 48 weeks in addition to the previous standard treatment(metformin and/or insulin) Body mass index(BMI). Timepoint: Weeks 0-12-24-48. Method of measurement: Weight in kilograms divided by height squared in meters. Evaluation of glycated hemoglobin or long-term blood sugar. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Fasting blood sugar measurement. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Measurement of glomerular filtration level for indirect evaluation of kidney status. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Measurement of urinary albumin / creatinine ratio. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Plasma creatinine measurement. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Measurement of urine albumin concentration. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Systolic and diastolic blood pressure. Timepoint: Weeks 0-12-24-48. Method of measurement: Barometer. Duration of diabetes. Timepoint: Week 0. Method of measurement: Using questionnaire. Evaluation of aspartate aminotransferase level for evaluation of liver function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Evaluation of alanine aminotransferase level for evaluation of liver function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Measurement of blood alkaline phosphatase level for evaluation of hepatic function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Measurement of blood triglyceride levels. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Patient quality of life. Timepoint: Weeks 0-12-24-48. Method of measurement: Using questionnaire. Measurement of blood cholesterol levels. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Measurement of blood LDL levels. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Measurement of blood HDL levels. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit. Insulin consumption. Timepoint: Weeks 0-12-24-48. Method of measurement: Using questionnaire. Metformin consumption. Timepoint: Weeks 0-12-24-48. Method of measurement: Using questionnaire. Angiotensin receptor blocker or Angiotensin converting enzyme inhibitors consumption. Timepoint: Weeks 0-12-24-48. Method of measurement: Using questionnaire. Lower limb edema. Timepoint: Weeks 0-12-24-48. Method of measurement: Questionnaire. Complications and cardiac events. Timepoint: Weeks 0-12-24-48. Method of measurement: Questionnaire. Incident of brain stroke. Timepoint: Weeks 0-12-24-48. Method of measurement: Questionnaire. Shahid Beheshti University of medical sciences Approved 2021-09-06 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highwa Tehran Tehran Iran (Islamic Republic of)