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IRCT20171030037093N11 IRCT 2019-05-08 Esfahan University of Medical Sciences The effect of linagliptin on microalbuminuria in diabetes patients The evaluation of the effect of linagliptin on microalbuminuria in type 2 diabetes patients with nephropathy 2019-05-20 anticipated 80 Complete https://irct.ir/trial/39062 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Cases are randomized using random allocation through the software. In this way, after the selection of 80 people that have the inclusion criteria, people are randomly assigned to one of the two intervention groups by statistical software, Blinding description: Drugs were packaged in the same package by the pharmacist, and none of the patients and researchers knew about their contents. 3 Diabetic nephropathy. Intervention 1: Intervention group: A group treated with lagglyptin 5 mg for 24 weeks. Intervention 2: Control group: A group treated with placebo for 24 weeks. 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 I will decide untill finishing the study
public Ashraf Aminorroaya
No. 9, Second Floor, Mulla Sadra Medical Complex, Amadgah Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3220 5915 aminorroaya@med.mui.ac.ir Esfahan University of Medical Sciences scientific Ashraf Aminorroaya
No. 9, Second Floor, Mulla Sadra Medical Complex, Amadgah Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3220 5915 aminorroaya@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with 6.5% to 10% glycated hemoglobin (hemoglobin HbA1c) (48 to 86 mmol / mol) Patients with BMI ≤ 40 kg / m² The level of albumin to creatinine (UACR) ranged from 30 to 3000 mg / g creatinine (in three urine samples consecutive two weeks before the start of the study) 18 years no limit Both Patients who consumed rapid acting insulin, rosiglitazone, pioglitazone, GLP-1 analogues, or anti-obesity drugs three months before the start of the study Patients who had myocardial infarction, stroke, or transient ischemic attack six months before the start of the study. Patients with non-diabetic renal insufficiency or urinary tract infection Patients who have received kidney transplants E11.21 Type 2 diabetes mellitus with diabetic nephropathy Treatment - Drugs Placebo Intervention group: A group treated with lagglyptin 5 mg for 24 weeks. Control group: A group treated with placebo for 24 weeks. Urine Albumin-to-Creatinine Ratio. Timepoint: In three urine samples collected consecutively two weeks before the start of the study and two weeks after the start of the study and then every 4 weeks. Method of measurement: Experiments. Blood pressure. Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: measurement. Body mass index. Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: measurement. Level glycosylated hemoglobin. Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: Experiments. Glomerular filtration rate (GFR). Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: MDRD formula. Liver Enzymes (ALT، AST، ALP). Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: Experiments. Profile Lipid (TG، LDL، HDL، total cholesterol). Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: Experiments. Esfahan University of Medical Sciences Approved 2018-09-26 Ethics Committee of Isfahan University of Medical Sciences Isfahn University of Medical Sciences, Hezar jarib st, Isfahan Isfahan Isfehan Iran (Islamic Republic of)