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Study aim
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To determine the effect of empagliflozin on blood pressure in diabetic patients with chronic kidney disease and to compare the outcomes with a control group.
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Design
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A randomized, double-blind, parallel-group, controlled clinical trial (Phase 3) conducted on 40 patients. For randomization, a stratified permuted block design (generated using R software) was employed.
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Settings and conduct
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Patient recruitment and follow-up will be conducted at the nephrology clinics of Zahedan University of Medical Sciences. Patients will be assigned to treatment groups receiving either empagliflozin (10 mg daily) or placebo (a similar-appearing multivitamin). Patients will be evaluated over three visits (baseline, 6-week, and 12-week visits) according to the protocol by Mayne et al. At each visit, systolic and diastolic blood pressures will be measured. Body weight will be assessed using a standardized and calibrated digital scale. Additionally, to evaluate kidney function, GFR and urinary albumin-to-creatinine ratio will be recorded in the data collection form.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Age ≥18 years with T2DM, Diagnosis of CKD (e.g., eGFR 20-60 mL/min/1.73m² or equivalent per study protocol), Hypertension (systolic BP ≥130 mmHg and/or diastolic BP ≥80 mmHg at baseline), Willingness to provide informed consent and comply with follow-up visits. Exclusion Criteria:Type 1 diabetes or secondary hypertension, Acute kidney injury, dialysis dependence, or history of kidney transplantation, Severe comorbidities (heart failure, liver disease, or malignancy), hypersensitivity to SGLT2 inhibitors (e.g., empagliflozin)
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Intervention groups
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Patients will be divided into two groups: one receiving empagliflozin treatment (10 mg daily) and the other receiving a placebo (a similar-appearing multivitamin).
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Main outcome variables
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Systolic and diastolic blood pressure