To compare salt taste and saliva characteristics in healthy volunteers and patients with CKD.
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Salt-sensitivity (as determined by salt taste testing), 24-hour blood pressure,
24-hour urinary excretion of sodium, plasma renin and aldosterone
concentrations.
Secondary outcome
- To correlate salt sensitivity thresholds to blood pressure, plasma renin and
aldosterone levels.
- To correlate salt sensitivity thresholds to differences in the salivary
proteome.
- To correlate salt sensitivity thresholds to the ability to activate ENaC in a
heterologous expression system (Xenopus oocytes).
Background summary
High dietary salt (NaCl) intake is one of the root causes of the high blood
pressure pandemic that drives premature cardiovascular and renal morbidity and
mortaility. There is a clear link between high dietary salt intake and these
pathalogical outcomes, but surprisingly little is known about human salt taste
in health and disease. Patients suffering from chronic kidney disease (CKD) are
charecterised by impaired salt taste which results in an even higher dietary
salt intake. It is known that epithelial sodium channels (ENaC) in the tongue
mediate salt taste. These channels can be cleaved via proteolytic cleavage as
is known from studies looking at ENaC in the kidney. Additionally, the salivary
proteome of healthy (salt-senisitive) subjects was shown to be enriched for
proteases, whereas CKD patients (salt-resistant) had more protease inhibitors.
With this study, we would like to explore wheter ENaC in the tongue are
proteolytically modulated by proteases in saliva, and if the high concentration
of protease inhibitors found in salt-resistant subject is responsible for the
reduced salt taste.
Study objective
To compare salt taste and saliva characteristics in healthy volunteers and
patients with CKD.
Study design
Observational study in which we will determine salt taste and collect saliva
samples in healthy subjects and CKD patients (n=20/group). The two groups will
be matched according to age and gender.
Study burden and risks
The study will consists of 3 study visits with 3x salt taste testing, 3x saliva
sample collections, 1x 24-hour urine collection, 1x 24-hour blood pressure
measurement, and 1x blood collection. These procedures may cause discomfort. If
patients use anti-hypertensive drugs that interfere with salt taste, the
measurements will be performed twice (with and without medication), resulting
in 6 study visits. During drug discontinuation, home blood pressure will be
monitored and (non-interfering) escape medication will ben provided, if
necessary.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
The patient group:
- Adult (>= 18 years)
- CKD (eGFR 15-44 ml/min/1.73 m2)
The group of healthy volunteers:
- Adult (>= 18 years)
Exclusion criteria
The exclusion criteria for the CKD patients:
- smoking
- any mouth disease
- Diabetes mellitus
- Use of any of the following drugs: clopidogrel, amiodaron, flecainide,
sotalol, propafenon.
- intellectual disability
The exclusion criteria for the healthy volunteers:
- smoking
- any mouth disease
- Hypertension (difined as office blood pressure > 140/90 mmHg)
- Reduced eGFR, albuminuria, or a known kidney disease
- Diabetes mellitus
- Intellectual disability
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74395.078.20 |