" Impact du Statut Alimentaire Sur la Fonction Vasculaire Avant et après un Petit-déjeuner standardisé. Une étude " exposé/Non exposé " nichée Dans la Cohorte SUVIMAX2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- High and low frequency peaks in systolic and diastolic blood pressure spectral analysis
研究概览
简要总结
In France, primary cardiovascular and metabolic prevention is supported by the French National Program for Nutrition and Health (PNNS: Programme National Nutrition Santé).
The investigators made the hypothesis that, independently of other diseases, the non adherence in PNNS guidelines would lead to arterial stiffness, endothelial dysfunction, change in microcirculation and in cardiac autonomic system. These changes may exist at fasting but also be reinforced after a standardised breakfast.
The investigators aim is to evaluate arterial stiffness, endothelial function, microcirculation and cardiac autonomic system according to PNNS status in a case control study.
详细描述
This is a case / control pilot nested in SU.VI.MAX 2 (SUpplémentation en VItamines et Minéraux Anti-oXydants) study. The randomized longitudinal placebo controlled SU.VI.MAX study tested the preventive effect of vitamin and antioxidant minerals supplementation on the incidence and the mortality from cardiovascular pathologies and cancers. SU.VI.MAX 2 was the extension of the previous study and included 7200 subjects for whom food habits were known and characterized according to PNNS guidelines (PNNS score).
The subjects will be pre-selected from the original cohort SU.VI.MAX2 if they have a PNNS score in 2007 in the 1-40th or 60-100th percentiles of distribution. If they accept to participate, a new PNNS score will be calculated in 2012-2013 and the subjects in the 1-25th or 75-100th percentiles will be included and explored during one day of participation.
Our aim is to evaluate arterial stiffness, endothelial function, microcirculation and cardiac autonomic system according to PNNS status in a case control study.
Our secondary objective is to evaluate the same parameters in the same subjects but after a breakfast containing 75 g glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Social Security affiliation.
- •Participation in SU.VI.MAX
- •Subjects without legal guardian who can freely agree to participate to the study.
- •PNNS score in 2012 lower (cases) or upper (controls) quartile.
排除标准
- •Known diabetes or prediabetes before the inclusion.
- •History of cardiovascular disease.
- •Treatment for hypertension.
- •Treatment for dyslipidemia.
- •Known Cancer
- •Smoking or patients that have stopped smoking less than 3 years
- •Cardiac pacemaker
研究组 & 干预措施
1-25th percentile of the PNNS score
干预措施: PNNS guidelines (Other)
75-100th percentile of the PNNS score
干预措施: PNNS guidelines (Other)
结局指标
主要结局
High and low frequency peaks in systolic and diastolic blood pressure spectral analysis
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Pulse Wave Velocity
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
This is a pilot study. Pulse wave velocity, an index of arterial stiffness, was chosen as the primary endpoint. A total of 47 subjects in each group was necessary to detect a difference between groups of 1m/s in pulse wave velocity (standard deviation of 1.7 m/s) with a statistical power of 80%, at fasting.
Peripheral arterial augmentation index (Aix )
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
High and low frequency peaks in heart variability spectral analysis
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Mean cutaneous blood flow measured by laser doppler flowmetry
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Mean cutaneous blood flow measured by laser doppler flowmetry, spectral analysis
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Percentage of variation of cutaneous blood flow laser doppler measurements after paced breathing (6/min)
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Increase in cutaneous blood flow laser doppler measurements after acetylcholine iontophoresis
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Reactive Hyperemia Index after branchial artery occlusion
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Aortic , radial,digital artery, systolic, diastolic and pulsatile pressures
时间窗: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
次要结局
- Comparison of the above mentioned parameters after a standardised breakfast(After the standardised breakfast that provides 75 gr of carbohydrates, hourly for the next 3 hours following the end of the standardised breakfast)