Skip to content

The Effect of Sodium on Erythrocyte Salt Sensitivity, Syndecan-1 and Heparin Sulfate in Healthy Subjects.

The Effect of Sodium on Erythrocyte Salt Sensitivity, Syndecan-1 and Heparin Sulfate in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06968182
Acronym
EGNA
Enrollment
27
Registered
2025-05-13
Start date
2016-05-18
Completion date
2017-01-13
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Renal Function, Sodium

Keywords

sodium, Renal Handling

Brief summary

The study was a double-blinded, randomized, placebo-controlled cross-over study. 27 healthy subjects received a four days standardized, sodium reduced diet (100 mmol sodium) and treatment with sodium chloride (200 mmol sodium) or placebo in a randomized order. After the treatment the subjects went to an examination day. With 1 L isotonic sodium chlorid intravenous in 25 minutes, the subjects were further sodium and volume loaded. Change in salt blood test (SaBT), syndecan-1(syn-1) and heparan sulfate (HS), brachial and central blood pressure (BP), pulse wave velocity (PWV) and augmentation index (AIx) were measured. Baseline blood samples were taken before the treatment periods

Detailed description

Background: The endothelium is lined with endothelial glycocalyx (EG). EG protects the endothelium and functions as a barrier between blood and endothelium. Due to negative charges EG has a strong ability to buffer sodium. In vitro studies indicate that sodium overload can damage the EG and reduce the sodium buffer capacity. This could cause endothelial dysfunction and might lead to cardiovascular disease. EG can be measured by the erythrocyte salt sensitivity (ESS) and shedding of glycocalyx. Purpose: The investigators aimed to examine the effect of dietary sodium balance on EG in healthy subjects. Methods: In a double blinded, randomized, placebo controlled cross over study, 27 healthy subjects received a four days sodium reduced diet and treatment with NaCl or placebo in randomized order. Afterwards the subjects were further sodium and volume loaded with 1 L isotonic NaCl intravenously. Changes in ESS and blood pressure were measured.

Interventions

DIETARY_SUPPLEMENTSodium Chloride

During the examination day after a baseline period, from 11.00 AM to 11.30 AM, a sustained infusion of 1 L isotonic NaCl, was administered.

Sponsors

Region MidtJylland Denmark
CollaboratorOTHER
Frank Mose
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Design The study was conducted as a randomized, double-blinded, placebo-controlled, crossover trial. Subjects received a four days standardized and sodium reduced diet and NaCl tablets or placebo in random order. Each treatment period was followed by an examination day. The examination days were separated by a wash-out period of at least three weeks.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Both gender * Age 18-50 years, * BMI 18.5-30.0 kg/m2, * Signed concent. * Fertile women with safe contraception during the whole examination period.

Exclusion criteria

* Alcohol consumption \> 7 drinks per week for women and, \> 14 drinks per week for men. * Smoking, * Substance abuse * Current use of medicine except contraception, * Office BP \> 140/90 * History or signs of clinically relevant kidney, heart, liver, lung, neurological, or endocrine diseases, neoplastic disorders, * Pregnancy or lactation * Blood donation within 1 month of the first investigation, * Clinically relevant abnormal blood/urine sample or electrocardiography. Withdrawal criteria: * Development of

Design outcomes

Primary

MeasureTime frameDescription
erythrocyte salt sensitivity (ESS)From enrollment and at the end of the second examination day, aprox. 3-4 monthseGC is in dynamic equilibrium between biosynthesis of new components and release of old. This is called shedding and the protein components can be measured in the plasma. Shedding is increased in e.g. sepsis, ischemia, kidney failure and severe bleeding {{38 Mulivor,A.W. 2004; 36 Salmon, Andrew H J AH 2012; 48 Sillesen,M. 2014; 49 Nelson,A. 2008; 50 Steppan,J. 2011}}{{35 Nieuwdorp,M. 2005}}. The erythrocytes (RBC) also posses a glycocalyx-layer. Intact glycocalyx of both endothelium and erythrocytes is important for maintenance of electrostatic forces and frictionless passage of the RBC through the capillaries{{20 Oberleithner,H. 2013; 26 Oberleithner,H. 2012; 7 Oberleithner,H. 2015}} Deterioration of eGC affect the RBC, and the surface of the RBC becomes a mirror image of the properties of eGC{{20 Oberleithner,H. 2013; 8 Oberleithner,H. 2014}}. Change in the RBC membrane can be demonstrated by a salt-blood test-mini{{18 Oberleithner,H. 2013; 99 Oberleithner,H. 2016}}. This is an

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026