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NCT Number: NCT07837076

Endothelial Function in Healthy Volunteers

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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 50 or over.
  • Able to give informed consent to take part in the research.
  • Enrolled in a social security system.

Exclusion criteria

  • 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.

Treatment and study plan

Measurement of endothelial function using FMD

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. SARC-F questionnaire

    Time frame: Baseline

    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.

  2. SPPB test

    Time frame: Baseline

    Muscle function will be assessed using the SPPB test, which assesses an individual's physical performance (balance, walking speed, standing up from a chair).

  3. Muscle strenght

    Time frame: Baseline

    Assessment of muscle strength in Kg using a dynamometer.

  4. Body composition: body fat

    Time frame: Baseline

    Body fat percentage will be measured using a bioimpedance analyser

  5. Body composition: lean body mass

    Time frame: Baseline

    Lean body mass percentage will be assessed using a bioimpedance analyser

  6. Body composition: body water

    Time frame: Baseline

    Body water percentage will be assessed using a bioimpedance analyser

  7. PSQI questionnaire

    Time frame: Baseline

    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.

  8. HAD scale

    Time frame: Baseline

    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.

  9. SF-36 questionnaire

    Time frame: Baseline

    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.

  10. Cognitive function assessment

    Time frame: Baseline

    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.

  11. Biological analyses

    Time frame: Baseline

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Endothelial Function in Healthy Volunteers (NormFMD)

Acronym: NormFMD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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