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Trial record 4 of 187 for:    BI10773

Empagliflozin and Renal Oxygenation in Healthy Volunteers (EMPA-REIN)

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ClinicalTrials.gov Identifier: NCT03093103
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Michel Burnier, Centre Hospitalier Universitaire Vaudois

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
Prescription of a placebo once a day Follow-up of renal parameters including BOLD MRI




Primary Outcome Measures :
  1. Renal oxygenation [ Time Frame: 18 months ]
    The acute and chronic effect of empagliflozin on renal oxygenation will be assessed by BOLD-MRI


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Michel Burnier, Prof +41 21 314 11 54 Michel.Burnier@chuv.ch
Contact: Anne Zanchi, MD PD Anne.Zanchi@chuv.ch

Locations
Switzerland
Service de Néphrologie Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Guler Gok-sogut, Ass-med    41 79 556 20 05    guler-gok-sogut@chuv.ch   
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Michel Burnier, Prof Service de Néphrologie CHUV

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Burnier, Professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03093103     History of Changes
Other Study ID Numbers: 2016-00099
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michel Burnier, Centre Hospitalier Universitaire Vaudois:
empagliflozin
kidney
BOLD-MRI

Additional relevant MeSH terms:
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs