Nephropathy Clinical Trial
Official title:
Effects of the SGLT2 Inhibitor Empagliflozin on Renal Tissue Oxygenation in Non-diabetic Subjects
SGLT-2 inhibitors belong to a new class of hypoglycemic drugs with the unique property of
decreasing blood glucose through an increase in glucosuria. These drugs inhibit the sodium
glucose transporter 2 (SGLT2) expressed at the luminal membrane of the proximal tubule.
SGLT-2 inhibition in type 2 diabetic subjects and in healthy volunteers shifts the threshold
for renal glucose excretion to lower levels. This effect is independent from insulin. The
inhibition of SGLT2 decreases HbA1C, systolic blood pressure and weight in diabetic subjects.
Recently, the EMPA-REG trial demonstrated a decrease in cardiovascular mortality and renal
endpoints in empagliflozin treated type 2 diabetic patients with established cardio-vascular
disease.
Because this novel hypoglycemic drug has unique and direct effects on renal tissue
metabolism, it is important to better examine its effects on the kidney. With this study, we
propose to explore the effects of empagliflozin on renal tissue oxygenation. Our hypothesis
is that SGLT-2 inhibition decreases renal cortical energy requirements with consequently an
increase in renal tissue oxygenation.
This study is a double-blind, randomized, placebo-controlled study that will examine the
acute and chronic renal effects of empagliflozin in healthy volunteers.
A total of 45 healthy volunteers will be included in the study: 15 normal weight, 15
overweight (BMI: 25-30kg/m2) and 15 obese (BMI>30kg/m2) non diabetic subjects (as determined
after an oral glucose tolerance test).
Empagliflozin 10mg vs placebo will be administered in a blinded fashion qd. The acute and
chronic renal response to empagliflozin will be assessed.
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