Diabetic nephropathy. Glomerular disorders in diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: In this study, the intervention includes the administration of empagliflozin as an adjunctive therapy to standard treatment with losartan in eligible patients with
Sponsors
Hamedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Confirmed type 2 diabetes (according to the file or ADA criteria). Presence of albuminuria (UACR> 30 mg/g). Taking losartan at a stable dose (25–100 mg) for at least 3 months before entry. Controlled blood pressure (SBP < 130 and DBP < 80 mmHg). eGFR = 30 mL/min/1.73 m². Willingness and written consent to participate in the study. No uncontrolled blood sugar. No chronic liver disease. No symptoms of active urinary and kidney infection. No acute conditions leading to hospitalization. No history of DKA. No urinary catheter. Age between 18 and 75 years. No history of other kidney diseases other than DN.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of empagliflozin on albuminuria and renal function (eGFR) in patients with type 2 diabetes with controlled blood pressure who are treated with losartan, over a period of 4 weeks. Timepoint: At the beginning of the study and 4 weeks later. Method of measurement: Serum creatinine is measured from a venous blood sample and estimated glomerular filtration rate (eGFR) is calculated based on the Cockcroft-Gault formula and reported as mL/min/1.73 m². | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of changes in albuminuria rate (UACR) between the two groups (empagliflozin + losartan vs. losartan alone) after 4 weeks of treatment. Timepoint: At the beginning of the study and 4 weeks later. Method of measurement: To assess albuminuria, spot urine samples were collected from patients at the beginning of the study and at the end of the fourth week, and the ratio of urinary albumin to creatinine (mg/g) was measured using standard laboratory methods.;Recording baseline metabolic parameters including HbA1c, fasting glucose, lipid profile (total cholesterol, LDL, HDL, triglycerides), and BMI as baseline variables and examining their role as predictive or confounding factors in response to treatment. Timepoint: At the beginning of the study and 4 weeks later. Method of measurement: Includes fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), and lipid profile (total cholesterol, LDL, HDL, and triglycerides), which are measured from a venous blood sample after at least 8 hours of fasting using standard laboratory methods.;To investigate the relationship between baseline metabolic parameters (HbA1c, lipid profile, BMI) and the response rate to empagliflozin in terms of changes in UACR and eGFR over 4 weeks. Timepoint: At the beginning of the study and 4 weeks later. Method of measurement: Patients' weight was measured with a calibrated scale and height with a standard sphygmomanometer, and BMI was calculated using the formula of weight (kilograms) divided by height squared (meters squared).;Comparison of changes in kidney function (eGFR and serum creatinine) between the two groups after 4 weeks of treatment. Timepoint: At the beginning of the study and 4 weeks later. Method of measurement: Serum creatinine levels are measured through a blood test using standard enzymatic methods in a hospital reference laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahmoud Ghalyaf
Hamedan University of Medical Sciences
Outcome results
None listed