Endothelial Function in Healthy Volunteers (NormFMD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Measurement of endothelial function using the FMD technique
研究概览
简要总结
The aim of this study is to measure FMD (flow-mediated dilation) in healthy volunteers aged over 50 in order to establish reference values for women aged over 50.
详细描述
The measurement of endothelial function using FMD (flow-mediated dilation) is a widely validated, non-invasive technique used in clinical research. FMD is considered a potential early marker of atherosclerosis. The investigators have been working for several years in collaboration with INRAE in Theix, where a number of observational and interventional studies have been carried out. Indeed, more than 400 patients, particularly women over the age of 50, have been included to investigate various clinical conditions such as nutritional disorders, cardiovascular disorders and rheumatological conditions. These studies have been the subject of several publications which have highlighted low FMD values in the presence of these comorbidities compared with European standards. However, these studies were retrospective and employed different methodologies, populations, techniques, equipment and investigators.
The investigators currently lack reference values to propose guidelines for more effective prevention of endothelial dysfunction. Furthermore, in several studies the investigators have highlighted correlations between FMD and muscle impairment and quality of life, using no reference standards other than those found in the literature - which also contains methodological biases - and they would also like to establish their own reference values in this context.
This study therefore aims to assess endothelial and muscle function, as well as quality of life, in healthy female volunteers with the aim of establishing reference values, under the same conditions and using the same methodology as in previous clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 50 or over.
- •Able to give informed consent to take part in the research.
- •Enrolled in a social security system.
排除标准
- •A history of cardiovascular disease (myocardial infarction, arterial disease) deemed by the investigator to be incompatible with the trial.
- •Medical and/or surgical history deemed by the investigator to be incompatible with the trial.
- •Treatment with lipid-lowering drugs, for high blood pressure or osteoporosis.
- •Women under legal guardianship or deprived of their liberty.
- •Refusal to participate.
研究组 & 干预措施
Healthy adult women
All the participants will be included in the only arm of this study designed to establish FMD values of reference.
干预措施: Measurement of endothelial function using FMD (Other)
结局指标
主要结局
Measurement of endothelial function using the FMD technique
时间窗: Baseline
The diameter of the brachial artery is measured by ultrasound before and after the increase in shear stress induced by the release of the occlusion after 5 minutes. The FMD of the left brachial artery is measured in the longitudinal plane above the antecubital fossa using a high-resolution CE-marked ultrasound scanner with a 190 linear array probe operating at 7 to 12 MHz. A mechanical arm (Vascular Imaging, Amsterdam, Netherlands), fitted with micrometric screws to allow precise movement in all three dimensions, is used to ensure correct, stereotactic positioning of the probe. Once the probe is optimally positioned, images are initially recorded for 60 s and then continuously for 3 min following the resolution of forearm ischaemia, caused by inflating a blood pressure cuff to 220 mmHg for 5 min (occlusion). The images are encoded and recorded on a dedicated computer, then digitised for subsequent blinded analysis using automatic edge-detection software 197.
次要结局
- SARC-F questionnaire(Baseline)
- SPPB test(Baseline)
- Muscle strenght(Baseline)
- Body composition: body fat(Baseline)
- Body composition: lean body mass(Baseline)
- Body composition: body water(Baseline)
- PSQI questionnaire(Baseline)
- HAD scale(Baseline)
- SF-36 questionnaire(Baseline)
- Cognitive function assessment(Baseline)
- Biological analyses(Baseline)
