Empagliflozin and Renal Oxygenation in Healthy Volunteers

Sponsor
Centre Hospitalier Universitaire Vaudois
Study ID
NCT03093103
Phase
PHASE2
Status
Completed

Conditions

  • Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin 10 mg — DRUG
    Prescription of empagliflozin 10 mg once a day Follow-up of renal parameters including BOLD MRI
  • Placebo — DRUG
    Prescription of a placebo once a day Follow-up of renal parameters including BOLD MRI

Study Details

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.

Key Dates

Start date
Mar 16, 2017
Status verified
Jul 2019
Primary completion
Dec 30, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: empagliflozin 10mg
    Empagliflozin (Jardiance) 10mg is an SGLT-2inhibitor. The drug will be taken qd for 4 weeks.
  • Placebo Comparator: Placebo
    Placebo will be taken qd for 4 weeks.

Primary Outcome Measure

Renal oxygenation [ Time Frame: 18 months ]

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