Endothelial Function in Healthy Volunteers (NormFMD)
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lise Laclautre
- Numer telefonu: +334754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Lokalizacje studiów
-
-
-
Clermont-Ferrand, Francja, 63000
- Rekrutacyjny
- Clinical Investigation Platform/Clinical Investigation Center, Inserm CIC 1405
-
Kontakt:
- Lise Laclautre
- Numer telefonu: +33473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
-
Kontakt:
-
Główny śledczy:
- Gisèle Pickering
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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). |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Measurement of endothelial function using the FMD technique
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
SARC-F questionnaire
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
|
Assessment of muscle strength in Kg using a dynamometer. |
Baseline
|
|
Body composition: body fat
Ramy czasowe: Baseline
|
Body fat percentage will be measured using a bioimpedance analyser |
Baseline
|
|
Body composition: lean body mass
Ramy czasowe: Baseline
|
Lean body mass percentage will be assessed using a bioimpedance analyser |
Baseline
|
|
Body composition: body water
Ramy czasowe: Baseline
|
Body water percentage will be assessed using a bioimpedance analyser |
Baseline
|
|
PSQI questionnaire
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Gisèle Pickering, University Hospital, Clermont-Ferrand
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RBHP 2026 PICKERING 2
- 2026-A01260-51 (Inny identyfikator: ANSM)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .