Endothelial Function in Healthy Volunteers
ConditionHealthy Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 50 or over.
Able to give informed consent to take part in the research.
Enrolled in a social security system.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Measurement of endothelial function using FMD
Other interventionFMD 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).
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Healthy adult womenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
BaselineSecondary outcomes
1
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
Baseline2
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
Baseline3
Muscle strenght
Assessment of muscle strength in Kg using a dynamometer.
Time frame
Baseline4
Body composition: body fat
Body fat percentage will be measured using a bioimpedance analyser
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov