hyponatremia syndrome of inappropriate antidiuresis
Conditions
Interventions
Capsaicin and tea (flavonoids) will be administered to examine the effects on
osmoregulation, kidney function and blood pressure with and without a
concurrent water load (WL). For the WL, 20mL/kg wa
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male between 18 and 40 years of age - Healthy as determined by a responsible and experienced physician, based on a medical evaluation, including medical history, physical examination (PE) and laboratory tests carried out in the screening visit. - Non-treated office blood pressure *135/85 mmHg - Body Mass Index (BMI) * 30kg/m2 - Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form.
Exclusion criteria
Exclusion criteria: * An office blood pressure * 135/85 mmHg * A body mass index * 30 kg/m2 * unwillingness to quit temporally being exposed to spicy food * A major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavourable for enrolment, including chronic inflammatory diseases. * A history of any type of malignancy within the past 5 years with the exception of succesfully treated basal cell carcinoma of the skin. * A history of any renal disease * A history of any blood clotting disorders * A history of any auto-immune disease * A history of cardiovascular disease (in the past 6 months) defined as documented coronary artery disease including myocardial infarction (MI), (un-)stable angina pectoris or acute coronary syndrome (ACS), precutenaous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), cerebrovascular disease, including ischaemic and hemorrhagic stroke or a subarachnoidal bleeding (SAB), or peripheral artery disease, including aortic aneurysmata (AA). * A history, within three years, of drugs abuse, including benzodiazepines, opioids, amphetamines, cocain and Cannabis (THC). * A history of alcoholism and/or drinking more than 3 units of alcohol per day. Alcoholism is defined as an average weekly intake > 21 units for males. One unit is equivalent to 8 g Of alcohol: a half-pint (240mL of beer), 1 glass (125mL) of wine or one measure (25mL) of hard liquor. * Smoking or usage of tabacco products less than 30 days ago. * Any other issue that in opinion of the investigator could be harmful to the subject or comprise interpretation of data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the control period-subtracted change in serum sodium induced after an oral administration of capsaicin or tea, with and without WL. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints hold plasma osmolality, co-peptin, vasopressin (AVP), RAAS hormones as well as urinary volume, urinary sodium excretion, and urinary osmolality. Also, blood pressure, body weight and body temperature will be measured. | — |
Countries
Netherlands
Outcome results
None listed