Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-Inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in the syndrome of inappropriate antidiuretic hormone (ADH) secretion (SIAD). Because patients with SIAD usually have several comorbidities and different medications, studies investigating the physiological effects are difficult to interpret. Therefore a model to study the possible physiological effect of SGLT2-inhibitors in hypotonic hyponatremia as in SIAD is needed. The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on serum sodium levels of healthy volunteers with induced hypotonic hyponatremia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Department Endocrinology University Hospital Basel
Basel, Basel, Switzerland
The primary outcome is the area under the curve (AUC) of the serum sodium concentration between time points 2 and 8 hours after administration of the study drug.
Time frame: concentration measured every hour within 8 hours after drug administration on both study days
Serum sodium concentration at every time point of the study
Time frame: every hour for twelve hours on each of the two study days
Amount of urinary excretion
Time frame: every 2 hours for twelve hours on each of the two study days
Serum osmolality at every time point of the study
Time frame: every hour for twelve hours on each of the two study days
Serum glucose at every time point of the study
Time frame: every hour for twelve hours on each of the two study days
Urinary osmolality
Time frame: every two hours for twelve hours on each of the two study days
Urinary glucose
Time frame: every 2 hours for twelve hours on each of the two study days
Serum electrolytes at time point -1, 0, 2 and 8
Time frame: 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Urinary electrolytes at time point -1, 0, 2 and 8
Time frame: 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Plasma level of Copeptin at time point -1, 0, 2 and 8
Time frame: 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Plasma level of Aldosterone at time point -1, 0, 2 and 8
Time frame: 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Plasma level of Renin at time point -1, 0, 2 and 8
Time frame: 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Plasma Level of atrial natriuretic peptide (ANP) at time point -1, 0, 2 and 8
Time frame: 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Plasma levels of brain natriuretic peptide (BNP) at time point -1, 0, 2 and 8
Time frame: 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Body weight at every time point of the study
Time frame: every hour during 12 hours on each of the two study days
Blood pressure at every time point of the study
Time frame: every hour during 12 hours on each of the two study days
Heart rate at every time point of the study
Time frame: every hour during 12 hours on each of the two study days
Symptoms of hyponatremia assessed by visual analogue scale (VAS) at every time point of the study
Time frame: every hour during 12 hours on each of the two study days
Urinary sodium level
Time frame: every 2 hours for twelve hours on each of the two study days
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