Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy.
Secondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).
Diagnosis of type 2 diabetes (HbA1C at or above 6.5%, or fasting blood glucose of more than 125 or random/ post prandial blood glucose of more than 199mg%)
African American veterans
Age 20-90 years
eGFR ≥25-89 mL/min/1.73 m2 by the CKD-EPI equation)
If a patient is on statin, need to be on a stable dose for a month.
Biopsy proven diagnosis of glomerular disease/glomerulonephritis
Active smokers,
Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
Parallel
Finerenone 10 MG
DrugTake Finerenone 10 mg orally daily
Empagliflozin 10 MG
DrugTake Empagliflozin 10 mg orally daily for 4 months
Urine Exosome Assay
To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine on empagliflozin or finerenone or combination therapy. Protein western analysis of Exosomes released from Kidney Podocyte is a indicator of kidney Podocyte health. Expressed as a ratio normalized
Renal Function - urine
Assessing kidney function by Microalbumin/Creatinine Ratio (Proteinuria) in the urine
Renal Function - serum
Estimated glomerular Filtration Rate (Egfr) assessing kidney function based on factors such as creatinine in the serum, age, sex, and ethnicity.
CD34 positive Cell Migratory Function
Proportion of cells that migrate through SDF1a in a transwell assay. A larger value indicates better migratory function of the CD34+ cells.
CD34 positive Cell Gene Expression
Evaluate mRNA gene expression focusing on vascular and endothelial function systemic markers which is normalized to 18s. Fold change of Gene Expression in participants with DKD relative to visit 1.
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Washington D.C. Veterans Affairs Medical Center
Lead sponsor
Bayer
Collaborator
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