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NCT Number: NCT03093103

Empagliflozin and Renal Oxygenation in Healthy Volunteers

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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Key information

Conditions

Nephropathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service de Néphrologie

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin 10 MG

Drug

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

Other names: Jardiance

Placebo

Drug

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

Primary outcomes

  1. Renal oxygenation

    Time frame: 18 months

    The acute and chronic effect of empagliflozin on renal oxygenation will be assessed by BOLD-MRI

Secondary outcomes

  1. Acute and chronic effects of empagliflozin on diurnal and nocturnal sodium, potassium, uric acid, calcium, phosphate, glucose and lithium clearances after 4 weeks treatment

    Time frame: 18 months

    Will be assessed on 24h urinary collections

  2. Acute and chronic effects of empagliflozin on renal resistance indexes and renal volume after 4 weeks treatment

    Time frame: 18 months

    Will be assessed by renal ultrasound

  3. Effects of empagliflozin on 24h blood pressure mesaurements

    Time frame: 18 months

    WIll be assessed by ambulatory blood pressure measurements

  4. Effect of body weight on the renal response to empagliflozin

    Time frame: 18 months

    Different groups of BMI will be evaluated

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Effects of the SGLT2 Inhibitor Empagliflozin on Renal Tissue Oxygenation in Non-diabetic Subjects

Acronym: EMPA-REIN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 28, 2017
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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