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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- erythrocyte salt sensitivity (ESS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Alcohol consumption > 7 drinks per week for women and, > 14 drinks per week for men.
- •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 exclusion criteria
- •Suspicion of poor compliance to study medication
- •Withdrawal of signed concent.
结局指标
主要结局
erythrocyte salt sensitivity (ESS)
时间窗: From enrollment and at the end of the second examination day, aprox. 3-4 months
eGC 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
次要结局
未报告次要终点
研究者
Frank Mose
Clinical Professor, Md. Ph.d.
Region MidtJylland Denmark