Empagliflozin and Renal Oxygenation in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised placebo-controlled double blind trial

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Placebo and Empagliflozin pills

Study Groups

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empagliflozin 10mg

Empagliflozin (Jardiance) 10mg is an SGLT-2inhibitor. The drug will be taken qd for 4 weeks.

Group Type ACTIVE_COMPARATOR

Empagliflozin 10 mg

Intervention Type DRUG

Prescription of empagliflozin 10 mg once a day Follow-up of renal parameters including BOLD MRI

Placebo

Placebo will be taken qd for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Prescription of a placebo once a day Follow-up of renal parameters including BOLD MRI

Interventions

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Empagliflozin 10 mg

Prescription of empagliflozin 10 mg once a day Follow-up of renal parameters including BOLD MRI

Intervention Type DRUG

Placebo

Prescription of a placebo once a day Follow-up of renal parameters including BOLD MRI

Intervention Type DRUG

Other Intervention Names

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Jardiance

Eligibility Criteria

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Inclusion Criteria

* Normal weight (BMI: 19-24.9kg/m2), overweight (BMI:25-30kg/m2) or obesity (BMI\>30kg/m2)
* Men and women (with a negative pregnancy test) during the follicular phase of the menstrual cycle. All groups will have a balanced number of men and women.
* OGTT/HbA1C: normal or pre-diabetes
* eGFR\>60ml/min, albumin/creatinine ratio \<3.3mg/mmol (\<30 mg/g)
* Signed consent form
* Normal renal ultrasound
* Normal urine dipstick

Exclusion Criteria

* Antihypertensive therapy
* NSAID treatment
* Former bariatric surgery
* Age\<18y or \>50y
* At risk of dehydration or hypotension
* Past history of recurrent genital or urinary tract infections
* Contra-indication for MR imaging (pacemaker or other implanted metallic device, claustrophobia)
* Pregnancy
* Sustained systolic blood pressure \>150mmHg or diastolic blood pressure \>95mmHg

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes