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Endothelial Function in Healthy Volunteers (NormFMD)

8. Oktober 2026 aktualisiert von: University Hospital, Clermont-Ferrand

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Healthy adult women

All the participants will be included in the only arm of this study designed to establish FMD values of reference.

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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Measurement of endothelial function using the FMD technique
Zeitfenster: 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.

Baseline

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
SARC-F questionnaire
Zeitfenster: 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.

Baseline
SPPB test
Zeitfenster: 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).

Baseline
Muscle strenght
Zeitfenster: Baseline

Assessment of muscle strength in Kg using a dynamometer.

Baseline
Body composition: body fat
Zeitfenster: Baseline

Body fat percentage will be measured using a bioimpedance analyser

Baseline
Body composition: lean body mass
Zeitfenster: Baseline

Lean body mass percentage will be assessed using a bioimpedance analyser

Baseline
Body composition: body water
Zeitfenster: Baseline

Body water percentage will be assessed using a bioimpedance analyser

Baseline
PSQI questionnaire
Zeitfenster: 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.

Baseline
HAD scale
Zeitfenster: 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.

Baseline
SF-36 questionnaire
Zeitfenster: 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.

Baseline
Cognitive function assessment
Zeitfenster: 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.

Baseline
Biological analyses
Zeitfenster: 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.

Baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Gisèle Pickering, University Hospital, Clermont-Ferrand

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

3. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. September 2026

Zuerst gepostet (Tatsächlich)

23. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • RBHP 2026 PICKERING 2
  • 2026-A01260-51 (Andere Kennung: ANSM)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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