VA Office of Research and Development
Empagliflozin, a sodium-glucose co-transporter 2 inhibitor (SGLT2i), is a novel diabetic medication that reduces the risk of progression of chronic kidney disease (CKD) and heart failure and improves exercise tolerance regardless of the diabetes status. One of the important ways that empagliflozin improves health may be through its benefits on blood vessels. The effects of empagliflozin on blood vessels and physical function have not been examined in patients with chronic kidney disease, and it is less clear if empagliflozin may be beneficial in patients with chronic kidney disease without heavy urinary protein leakage. The investigators will examine if empagliflozin can improve blood vessel function and exercise tolerance in Veterans with chronic kidney disease without heavy urinary protein leakage.
Overall Strategy: The investigators propose a randomized, double-blind, placebo-controlled, phase-II study in 52 Veterans with non-diabetic CKD without heavy albuminuria (\<300 mg/g) and eGFR 20-59 mL/min/1.73m2 to investigate if empagliflozin, a selective SGLT2i, can improve vascular function, functional capacity, and plasma biomarkers of inflammation, oxidative stress, and nitric oxide (NO). Veterans will be recruited from the Salt Lake City VA and randomized to 10 mg of empagliflozin or placebo at 1:1 ratio and treated for 16 weeks. Overarching Hypothesis: SGLT2 inhibition improves endothe…
Inclusion Criteria: * eGFR (estimated glomerular filtration rate) 20-59 mL/min (milliliters per minute) * albuminuria \<300 mg/g (milligrams per gram) Exclusion Criteria: * Type 1 or 2 diabetes mellitus * expected to start dialysis or receive kidney transplantation or die within 4 months * prior therapy with SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors) within the previous year * unable to participate in the physical function tests (hand grip, walk) * infections requiring intravenous antibiotic treatment * malignancy requiring systemic therapy * extremity skin ulceration requiring act…
Empagliflozin 10 mg, encapsulated to match the placebo, will be used.
Matching placebo will be used.
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