Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study (DIVE)
Inappropriate ADH Syndrome
About this trial
This is an interventional treatment trial for Inappropriate ADH Syndrome focused on measuring Hyponatremia, SGLT2 inhibitor
Eligibility Criteria
Inclusion Criteria:
- Informed consent as documented by signature
- Age 18 to 65 years
- serum sodium level 135-145mmol/l
- clinically euvolemic status
Exclusion Criteria:
- Known or suspected allergy to trial product or related products
- Pregnancy or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- untreated hypothyroidism
- cortisol deficiency
- history of heart failure
- liver cirrhosis at any stage
- kidney disease (GFR <60ml/min)
- epileptic seizures within the last year
- uncontrolled hypertension (systolic blood pressure >160mmHg)
- Diabetes mellitus type 1 or 2
- BMI <18 or >29kg/m2
- other severe disease
Sites / Locations
- Department Endocrinology University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Empagliflozin 25mg Tbl
Placebo P-Tablet
Induced hypotonic hyponatremia - SIAD model: Hypotonic hyponatremia will be induced in healthy volunteers through oral overhydration and parenteral administration of desmopressin (Minirin)® 4ug. After administration of the study drug, the artificial SIAD will be sustained with infusion of hypotonic sodium-solution (NaCl 0.45%) over two hours.
Induced hypotonic hyponatremia - SIAD model: Hypotonic hyponatremia will be induced in healthy volunteers through oral overhydration and parenteral administration of desmopressin (Minirin)® 4ug. After administration of the study drug, the artificial SIAD will be sustained with infusion of hypotonic sodium-solution (NaCl 0.45%) over two hours.