Comparative Evaluation of the Effect on Blood Pressure of an Equivalent Content of Sodium in the Form of Bicarbonate of Sodium and in the Form of Sodium Chloride, on "Sensitive Sodium" Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Average value of the mean blood pressures
研究概览
简要总结
Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce consumption about 20%, by limiting contributions of sodium in prepared foods, bread.
In terms of basic and clinical research, the biological effects of sodium chloride dietary intake, have been the subject of numerous studies for several decades. This work showed that all subjects do not react uniformly to sodium chloride flows, determining what the investigators call people "sodium-sensitive". For these people the sodium intake elevated blood pressure, much more marked than in subjects called "sodium-resistant."
"Sodium-sensitive" people represent 10 to 30% of the population. A marked over-representation of this phenotype was observed in patients with hypertension or a family history of hypertension.
In addition, studies conducted in animals and humans indicate that sodium intake has a different impact on biological parameters mentioned above, as is done in the form of chloride salt or bicarbonate of sodium.
Based on these factors, investigators developed a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.
详细描述
Pre-selection: Clinical Pharmacology Center or Cardiology department
Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center
- Signature of informed consent form
- Check of eligibility criteria
- Clinical exam
- Blood pressure measure
- Blood sample (for renal biology)
- Collection of concomitant treatments
- Collection of food habits
- Delivery of the dietary instructions and forbidden treatments
Phenotyping period : (192 subjects)
All the 192 subjects will realize the 3 first visits in order to determine if yes or no the subjects are "Sodium sensitive".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Systolic Blood pressure between 130-160 mmHg and/or diastolic 90-100, not treated and/or family history of arterial high blood pressure (Father or Mother),
- •Between 18 and 75 years old
- •Asymptomatic on the cardiovascular plan,
- •Absence of known heart disorder,
- •Brachial Perimeter between 22 and 42 cms,
- •Creatinine clearance in the standards dating less than 12 months, (glomerular filtration rate > 60 ml / mn / 1.73m²),
- •Agreeing to drink some sparkling water during the periods of study,
- •Effective method of birth control for women with childbearing potential
- •Cooperation and understanding enough to conform to the study obligations
- •Voluntary gives written informed consent to participate in the study
- •Affiliated at system of French social security
- •Inscription or acceptation of inscription in the national register of volunteers involved in trials.
排除标准
- •-Treated by corticoids
- •Treated by prohibited medications
- •Pregnant or breastfeeding
- •Treated by anti-hypertensive drug
- •History of heart disease or ischemic heart disease
- •Lack of sinus rhythm
- •Renal insufficiency (glomerular filtration rate > 60 ml / mn / 1.73m ²)
- •Uncontrolled hypertension (> 160 / 100mmHg)
- •Incompatible comorbidity with the study
- •BMI > 35 kg / m2
- •Invalidating cognitive disorders
- •Anxiety to use the device to measure blood pressure alone at home judged by the investigator
- •Diabetes (Type I and II)
- •Chronic alcoholism
- •Sports judged as intense (more than 3 hours per week of intense sports),
- •Participation in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial,
- •Cooperation and understanding that do not allow him to follow the trial,
- •Patients with minor or under guardianship.
研究组 & 干预措施
NaCI group
a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.
干预措施: Sodium Bicarbonate and Sodium chloride (Drug)
placebo NaCI
a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.
干预措施: Sodium Bicarbonate and Sodium chloride (Drug)
结局指标
主要结局
Average value of the mean blood pressures
时间窗: during the last 3 days of each of the 2 periods of treatment of 14 days
Average value of the mean blood pressures, collected with the device Microlife BP A200, in the morning and evening during the last 3 days of each of the 2 periods of treatment of 14 days.
次要结局
- Values of fat mass, dry mass and water by impedancemetry.(during the last 3 days of each of the 2 periods of treatment of 14 days)
- Value of Pulse Pressure (PP), with device Sphygmocor ®,(during the last 3 days of each of the 2 periods of treatment of 14 days.)
- Value of the Increase Index (AIX) with the Sphygmocor ®,(during the last 3 days of each of the 2 periods of treatment of 14 days.)
- Biological assay Aldostéron (pg/ml)(during the last 3 days of each of the 2 periods of treatment of 14 days)
- Biological Assay of the Endotheliales microparticles (nb/µl)(during the last 3 days of each of the 2 periods of treatment of 14 days)
- Value of Aortic Systolic Pressure (SP) with device Sphygmocor ®,(during the last 3 days of each of the 2 periods of treatment of 14 days.)
- Value of the Pusle Wave Velocity with the Sphygmocor ®,(during the last 3 days of each of the 2 periods of treatment of 14 days.)
- Biological assay Angiotensine II (UECA)(during the last 3 days of each of the 2 periods of treatment of 14 days)
- Biological assay of Renine (pg/ml)(during the last 3 days of each of the 2 periods of treatment of 14 days)