Healthy WomenNormFMDNCT07837076
Endothelial Function in Healthy Volunteers
A study testing Measurement of endothelial function using FMD in people with Healthy Women, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Measurement of endothelial function using FMD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 50 or over.
- Able to give informed consent to take part in the research.
- Enrolled in a social security system.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinical Investigation Platform/Clinical Investigation Center, Inserm CIC 1405
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
promo_interne_drci@chu-clermontferrand.fr
About this study
Official title: Endothelial Function in Healthy Volunteers (NormFMD)
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.
Read the detailed description
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.
- Conditions
- Healthy Women
- Being tested
- Measurement of endothelial function using FMD
- Keywords
- endothelial function, healthy women, arteriosclerosis
- Medical subject headings
- Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of endothelial function using FMDOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult women | Experimental | All the participants will be included in the only arm of this study designed to establish FMD values of reference. Receives: Other: Measurement of endothelial function using FMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (11)
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.
Measured: 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).
Measured: Baseline
Muscle strenght
Assessment of muscle strength in Kg using a dynamometer.
Measured: Baseline
Body composition: body fat
Body fat percentage will be measured using a bioimpedance analyser
Measured: Baseline
Body composition: lean body mass
Lean body mass percentage will be assessed using a bioimpedance analyser
Measured: Baseline
Body composition: body water
Body water percentage will be assessed using a bioimpedance analyser
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start5 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle Pickering, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837076
- Sponsor's protocol ID
- RBHP 2026 PICKERING 2
- Other IDs
- 2026-A01260-51
- Acronym
- NormFMD
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function in Healthy Volunteers (NormFMD)
- ClinicalTrials.gov ID
- NCT07837076
- Acronym / sponsor ID
- NormFMD / RBHP 2026 PICKERING 2
- Conditions
- Healthy Women
- Keywords
- endothelial function, healthy women, arteriosclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult women | Experimental | Other: Measurement of endothelial function using FMDAll the participants will be included in the only arm of this study designed to establish FMD values of reference. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 50 or over.
- Able to give informed consent to take part in the research.
- Enrolled in a social security system.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of endothelial function using FMDFMD 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). | Other | Healthy adult women |
Primary outcome
Measurement of endothelial function using the FMD technique
Time frame: 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.
11 secondary outcomes
SARC-F questionnaire
Time frame: Baseline
SPPB test
Time frame: Baseline
Muscle strenght
Time frame: Baseline
Body composition: body fat
Time frame: Baseline
Body composition: lean body mass
Time frame: Baseline
Body composition: body water
Time frame: Baseline
PSQI questionnaire
Time frame: Baseline
HAD scale
Time frame: Baseline
SF-36 questionnaire
Time frame: Baseline
Cognitive function assessment
Time frame: Baseline
Biological analyses
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gisèle Pickering principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of endothelial function using FMD in people with Healthy Women, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+334754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of endothelial function using the FMD technique (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.