Empagliflozin and Renal Oxygenation in Healthy Volunteers (EMPA-REIN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03093103|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : November 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Nephropathy||Drug: Empagliflozin 10 mg Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised placebo-controlled double blind trial|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Placebo and Empagliflozin pills|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of the SGLT2 Inhibitor Empagliflozin on Renal Tissue Oxygenation in Non-diabetic Subjects|
|Actual Study Start Date :||March 16, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Active Comparator: empagliflozin 10mg
Empagliflozin (Jardiance) 10mg is an SGLT-2inhibitor. The drug will be taken qd for 4 weeks.
Drug: Empagliflozin 10 mg
Prescription of empagliflozin 10 mg once a day Follow-up of renal parameters including BOLD MRI
Other Name: Jardiance
Placebo Comparator: Placebo
Placebo will be taken qd for 4 weeks.
Prescription of a placebo once a day Follow-up of renal parameters including BOLD MRI
- Renal oxygenation [ Time Frame: 18 months ]The acute and chronic effect of empagliflozin on renal oxygenation will be assessed by BOLD-MRI
- 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
- 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
- Effects of empagliflozin on 24h blood pressure mesaurements [ Time Frame: 18 months ]WIll be assessed by ambulatory blood pressure measurements
- Effect of body weight on the renal response to empagliflozin [ Time Frame: 18 months ]Different groups of BMI will be evaluated
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093103
|Contact: Michel Burnier, Prof||+41 21 314 11 54||Michel.Burnier@chuv.ch|
|Contact: Anne Zanchi, MD PD||Anne.Zanchi@chuv.ch|
|Service de Néphrologie||Recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Guler Gok-sogut, Ass-med 41 79 556 20 05 firstname.lastname@example.org|
|Contact: Marie-Eve Muller, MD 41 79 556 59 46 Marie-Eve.Muller@chuv.ch|
|Sub-Investigator: Anne Zanchi, MD|
|Principal Investigator: Michel Burnier, Prof|
|Principal Investigator:||Michel Burnier, Prof||Service de Néphrologie CHUV|