Comparison on Blood Pressure Effect of an Equivalent Sodium Intake, With Different Nature, for Hypertensive Subjects (SODIVASC-II)
Comparative Evaluation on Blood Pressure Effect of an Equivalent Sodium Intake, in the Form of Bicarbonate or Chloride, for Hypertensive Subjects.
Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. In France, according to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), salt intakes could be estimated from 2 national food consumption surveys INCA 1 and INCA 2. This made it possible to take a photograph of food consumption habits and to show that the average consumption of salt contained in food in France is 8.7g/day for men and 6.7g/day for women. To these contributions must also be added 1 to 2g of salt for the resalting and the cooking water. According to the food consumption survey INCA 3, french plate still contains a large part of processed foods and still a little too much salt (on average 9g/day for men and 7g/day for women at compare with the objectives of the National Health Nutrition Program of 8g/day and 6.5g/day respectively). In addition, the World Health Organization (WHO) recommends consuming less than 5g of salt per day.
In this context, sodium intake through mineral water was also questioned. Both in terms of basic and clinical research, the biological effects of dietary sodium chloride intake have been the subject of a great deal of work for several decades. The mechanisms of transmission in the induced or hemodynamic effects related to the absorption of Na multiple debates and their impact on cardiovascular risks remain very uncertain. Work has shown that all subjects do not react homogeneously to sodium chloride intakes, thus determining what are called "NaCl-sensitive" people who in a situation of major sodium intake will show an increase of peripheral vascular resistance and an increase in blood pressure, much more marked than in subjects called " NaCl resistant ".
"NaCl-sensitive" people represent 10 to 30% of the population, with notable differences according to ethnic origins, regions and continents. A marked overrepresentation of this phenotype is observed in patients with hypertension or with a family history of hypertension.
Furthermore, studies conducted on animals and humans show that sodium intake does not have the same impact on the parameters mentioned above, depending on whether it is in the form of chloride or bicarbonate salt.
On the basis of these elements, the investigators developed a clinical study protocol intended to demonstrate a possible differential effect in the biological effects of the same sodium orally intake (2.56g per day), depending on the salt origin.
調査の概要
詳細な説明
This single-center, randomized study, aim to determine the difference in absorption between sodium depending on its nature: bicarbonate (NaHCO3) or chloride (NaCl), and the effect of those types of sodium on blood pressure.
In order to realize it, 206 volunteers will be include to assess whether or not they are a "NaCl sensitive volunteer" phenotype.
The study will be carried out on 34 of NaCl sensitive volunteer which will take the sodium dietary supplements. The 2 dietary supplements are table salt (sachet) or bottled water. They will be test in a cross-over design during 2 periods of 1 week separated from 1 week of a washing-out period.
The primary objective will be to compare mean arterial pressure (MAP) resulting from daily supplementation of 2.56 g of sodium (111 mmol), in addition to the food intake of a low-sodium diet from V2 to the end of the study (<5g of NaCl / day), for 7 days, either as sodium chloride or as sodium bicarbonate in hypertensive subjects.
This clinical trial will be separated in 2 phases:
Phenotyping (4 visits): to determine if the volunteer is "NaCl sensitive volunteer" or not
- V1 (day -28/D-28) = inclusion and beginning of phenotyping phase,
- V2 (day -21/D-21) = start of a low-sodium diet (<5g of NaCl / day),
- V3 (day -14/D-14) = daily supplementation of sodium chloride for 7 days (9.78g/day),
- V4 (day -7/D-7) = "NaCl sensitive volunteer" assessment, end of study for "NaCl non-senstive volunteers".
Treatment period for "NaCl sensitive volunteer" with dietary supplement intake in a cross-over design:
- PC1 (day 0/D0) = beginning of treatment period 1,
- PC2 (day 3/D3) = volunteer contact to make sure he is all right,
- V5 (day 7/D7) = end treatment period 1,
- PC3 (day 14/D14) = beginning of treatment period 2,
- PC4 (day 17/D17) = volunteer contact to make sure he is all right,
- V6 (day 21/D21) = end of treatment period 2 and of the study.
The protocol includes a total of 6 visits to PIC/CIC Inserm 1405 of the Clermont-Ferrand University Hospital.
The maximum duration of the study will be of 7 weeks.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lise LACLAUTRE, PharmD
- 電話番号：04 73 75 11 95
- メール：drci@chu-clermontferrand.fr
研究場所
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Auvergne
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Clermont-Ferrand、Auvergne、フランス、63000
- Platform of Clinical Investigation / Clinical Investigation Center French Institute of Health and Medical Research-1405 University Hospital
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コンタクト：
- Louis LE GUEN
- 電話番号：04 73 75 17 84 13
- メール：lleguen1@chu-clermontferrand.fr
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コンタクト：
- Marion COURRENT
- 電話番号：04 73 75 17 84 24
- メール：mcourrent@chu-clermontferrand.fr
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主任研究者：
- Gisele PICKERING, MD, PhD & PharmD
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副調査官：
- Christian DUALE, MD, PhD
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副調査官：
- Gilles DUCHEIX, MD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Systolic blood pressure between 135-160 mmHg and diastolic 85-100 in self-measurement, untreated or treated but not balanced under treatment,
- Father or mother hypertensive,
- Weight ≥ 50 kg
- Absence of known heart disease,
- Brachialis perimeter between 22 and 42 cm,
- Creatinine clearance within the standards dating from less than 12 months, (GFR> 60ml / min / 1.73m²),
- Agreeing to drink sparkling water during one of the study periods,
- Effective contraception for female subjects of childbearing age,
- Cooperation and understanding sufficient to comply with the requirements of the test,
- Affiliated with a Social Security scheme,
- Agreeing to give written consent,
- Registration or acceptance of registration in the national register of volunteers participating in research.
Exclusion Criteria:
- Consumption of more than 5g/day of salt in the protocol diet (evaluated by natriuresis analyzed in V3)
- Systemic corticosteroid therapy
- Taking prohibited drugs (see list) and at the judgment of the investigator.
- Suffering from pulmonary hypertension
- Woman of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman,
- History of cardiomyopathy or ischemic heart disease,
- Absence of sinus rhythm,
- Renal failure (DFG <60 ml/min/1.73m²),
- Comorbidity incompatible with the study,
- BMI> 35 kg/m2,
- Disabling cognitive disorders,
- Anxiety when taking measurements alone at home at the judgment of the investigator,
- Diabetes (Type I and II)
- Chronic alcoholism,
- Sports activity deemed to be intense (more than 3 hours / week of intense sport),
- Extreme sweating activity (Sauna, Hammam),
- During participation in another clinical trial, or in the exclusion period, or having received a total amount of compensation greater than 4,500 euros over the 12 months preceding the start of the trial,
- Benefiting from a legal protection measure (curatorship, guardianship, deprived of freedoms, safeguard of justice)
- Not affiliated with the French Social Security scheme.
- Any history deemed significant by the investigator.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Bottle of water
After inclusion in the study, the patients are phenotyped between V1 and V4.
Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients.
The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt.
|
After inclusion in the study, between V1 and V4, patients will be phenotyped among: "NaCl sensitive" patients and "non-NaCl sensitive" patients.
they will have a low sodium diet for 2 weeks.
The first week without salt supplementation and the second with salt supplementation.
At the end of V4, if patient is "NaCl sensitive" he will continue into treatment period and go through randomization, and for patient "non-NaCl sensitive" they will drop out of study.
After being phenotyped, "NaCl sensitive" patients will continue the study in one of the 2 treatments arms : royal water (bottle) or salt sachet.
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|
アクティブコンパレータ：Salt sachet
After inclusion in the study, the patients are phenotyped between V1 and V4.
Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients.
The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt.
|
After inclusion in the study, between V1 and V4, patients will be phenotyped among: "NaCl sensitive" patients and "non-NaCl sensitive" patients.
they will have a low sodium diet for 2 weeks.
The first week without salt supplementation and the second with salt supplementation.
At the end of V4, if patient is "NaCl sensitive" he will continue into treatment period and go through randomization, and for patient "non-NaCl sensitive" they will drop out of study.
After being phenotyped, "NaCl sensitive" patients will continue the study in one of the 2 treatments arms : royal water (bottle) or salt sachet.
|
|
他の：No treatment
After inclusion in the study, the patients are phenotyped between V1 and V4.
Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients.
The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt.
|
After inclusion in the study, between V1 and V4, patients will be phenotyped among: "NaCl sensitive" patients and "non-NaCl sensitive" patients.
they will have a low sodium diet for 2 weeks.
The first week without salt supplementation and the second with salt supplementation.
At the end of V4, if patient is "NaCl sensitive" he will continue into treatment period and go through randomization, and for patient "non-NaCl sensitive" they will drop out of study.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from mean blood pressure (MBP) at Day 21
時間枠：Day 21
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Comparison between blood pressure data recorded by the volunteer between the 2 weeks of treatment (measurement during 2 days before Day 7 and 2 days before Day 21). Recording of systolic and diastolic blood pressure will be made by the patient at home with the Microlife BP A200 device, in the morning and evening. Comparison of the data collected from these 2 weeks of treatment will allow us to meet the main objective of the study. |
Day 21
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from mean blood pressure (MBP) at Day -7
時間枠：Day -7
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Comparison between blood pressure data recorded by the volunteer for the last 2 days before Day -14 and the last 2 days before Day -7. Recording of systolic and diastolic blood pressure will be made by the patient at home with the Microlife BP A200 device, in the morning and evening to determine if the subject is "NaCl sensitive" or not. |
Day -7
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Weight
時間枠：Day -28, Day -21, Day -14, Day -7, Day 7 and Day 21
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Measure of patient weight (in kilograms) using a weighing machine.
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Day -28, Day -21, Day -14, Day -7, Day 7 and Day 21
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Body composition analysis
時間枠：Day -21, Day -14, Day -7, Day 7 and Day 21
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Measurement of water quantities in the body, fat and muscle, will be analyzed using an non-invasive device by impedance measurement.
Patient will be comfortably installed in a quiet room, lying down on a bed where two electrodes will be applied, one at the level of the hand, the other at the level of the foot.
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Day -21, Day -14, Day -7, Day 7 and Day 21
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Optional genotyping
時間枠：One time at Day -28
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With patient agreement: 1 tube of blood (9mL) used for genetics analysis: genotyping
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One time at Day -28
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Plasma renin dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of renin in plasma (ng/mL/h) will be measured on fasted state.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Plasma Angiotensin II dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of angiotensin II (µg/L) in plasma will be measured on fasted state.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Plasma Aldosterone dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of aldosterone (pg/mL) in plasma will be measured on fasted state.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Plasma potassium dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of potassium (mmol/L) in plasma will be measured on fasted state.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Plasma sodium dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of sodium (mmol/L) in plasma will be measured on fasted state.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Plasma calcium dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of calcium (mmol/L) in plasma will be measured on fasted state.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Plasma chlorine dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of chlorine (mmol/L) in plasma will be measured on fasted state.
|
Day -28, Day -14, Day -7, Day 7 and Day 21
|
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Plasma protein dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of protein (mmol/L) in plasma will be measured on fasted state.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Serum creatinine dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of creatinine (mmol/L) in serum will be measured on fasted state.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Serum urea dosage on fasted state
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of urea (mmol/L) in serum will be measured on fasted state.
|
Day -28, Day -14, Day -7, Day 7 and Day 21
|
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Sodium concentration in 24h urine
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of sodium in urine (mmol/24h) will be measured.
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Day -28, Day -14, Day -7, Day 7 and Day 21
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Potassium concentration in 24h urine
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of potassium in urine (mmol/24h) will be measured.
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Day -28, Day -14, Day -7, Day 7 and Day 21
|
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Creatinine concentration in 24h urine
時間枠：Day -28, Day -14, Day -7, Day 7 and Day 21
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Concentration of creatinine in urine (mmol/24h) will be measured.
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Day -28, Day -14, Day -7, Day 7 and Day 21
|
協力者と研究者
捜査官
- 主任研究者：Gisele PICKERING, MD、Platform of Clinical Investigation/Clinical Investigation Center French Institute of Health and Medical Research-1405 63000 Clermont-Ferrand FRANCE
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RBHP 2021 PICKERING 3
- 2021-A01134-37 (その他の識別子：ANSM)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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