An interventional study of Measurement of endothelial function using FMD in Healthy Women, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other
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.
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.
157 studies on the registry are indexed under Arteriosclerosis; 18 are open to participants now.
This study's planned enrollment of 50 is below the median of 109 across 104 interventional studies indexed under Arteriosclerosis.
Browse Arteriosclerosis studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All the participants will be included in the only arm of this study designed to establish FMD values of reference.
Other: Measurement of endothelial function using FMD
FMD refers to the increase in the diameter of the brachial artery caused by hyperaemia resulting from the rapid deflation of a cuff inflated to a suprasystolic pressure. This measurement of endothelial function is carried out at the level of the microcirculation (peripheral vessels) using the non-invasive technique of measuring flow-mediated vasodilation (FMD) in the brachial artery, which is currently the gold standard for assessing vascular endothelial function in humans (Holder et al., 2021).
Measurement of endothelial function using the FMD technique
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.
Time frame: Baseline
SARC-F questionnaire
Muscle function will be assessed using the SARC-F questionnaire, where a score of 4 out of 5 or higher suggests the presence of sarcopenia.
Time frame: Baseline
SPPB test
Muscle function will be assessed using the SPPB test, which assesses an individual's physical performance (balance, walking speed, standing up from a chair).
Time frame: Baseline
Muscle strenght
Assessment of muscle strength in Kg using a dynamometer.
Time frame: Baseline
Body composition: body fat
Body fat percentage will be measured using a bioimpedance analyser
Time frame: Baseline
Body composition: lean body mass
Lean body mass percentage will be assessed using a bioimpedance analyser
Time frame: Baseline
Body composition: body water
Body water percentage will be assessed using a bioimpedance analyser
Time frame: Baseline
PSQI questionnaire
Quality of life will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which measures sleep quality during the month preceding the interview with the participant. The overall score (0 to 21) is calculated by adding together the sub-scores for the seven components, each of which ranges from 0 to 3 points. The higher the overall score, the greater the impairment to sleep quality. An overall score of more than 5 is an indicator of sleep disorders.
Time frame: Baseline
HAD scale
Quality of life will be assessed using the Hospital Anxiety and Depression (HAD) scale, which screens for anxiety and/or depressive disorders. It comprises 14 items scored from 0 to 3. Seven questions relate to anxiety and seven others to the depressive dimension, thus yielding two scores (maximum score for each: 21). A score of 7 or below indicates an absence of symptoms. A score between 8 and 10 indicates possible symptoms. A score of 11 or above indicates confirmed symptoms.
Time frame: Baseline
SF-36 questionnaire
Quality of life will be assessed using 36-Item Short Form Survey (SF-36), which assesses an individual's physical and mental health based on 36 questions relating to eight aspects of health. An index is calculated for both physical and mental health (0-100); the higher the score, the better the quality of life.
Time frame: Baseline
Cognitive function assessment
The cognitive assessment will be carried out using the MoCA test, which is a screening tool for cognitive decline that provides a comprehensive assessment of cognitive functions by examining: memory, visuospatial ability, executive functions, concentration and attention, language and spatial orientation.
Time frame: Baseline
Biological analyses
A blood sample (28 mL in total) will be taken after fasting to analyse the lipid profile, certain bone markers (FGF23, vitamin D) and genetic/epigenetic markers.
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 12 months after the start.
Of 29 interventional studies with no phase under Arteriosclerosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 12 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 9, 2026: start Sep 2026 → Oct 2026, primary completion Sep 2027 → Oct 2027 and completion Sep 2027 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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