PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty (PRO-FGF)
Comparative Study of Postprandial Fibroblast Growth Factor-19 (FGF-19) Secretion Kinetics in Older Adults With or Without Frailty
Fibroblast Growth Factor 19 (FGF-19) is an intestinal hormone secreted in the post-prandial state, whose primary role is to inhibit bile acid synthesis in the liver. It is expressed by the FXR (Farnesoid X receptor) nuclear receptor in the enterocytes of the ileum, which is activated by specific bile acids metabolized in the gut microbiota. It was demonstrated that treatment with FGF-19 induces myofiber hypertrophy in vitro and increases muscle strength and mass in mice model of sarcopenia. Sarcopenia and the commonly associated physical frailty, are age-related syndromes associated with adverse events (such as falls and fractures, mobility disability) and increased mortality. Currently, there is no drug treatment that has been proven effective to counteract those syndromes and standard care consists in non-pharmacological interventions (exercise and nutrition) whose implementation remains complex due to several barriers. Moreover, the anabolic resistance underlying sarcopenia hampers the exercise-induced response on muscle mass and the level of evidence for this outcome remains poor-to-moderate. Thus, FGF-19 could be considered as a new regulator of skeletal muscle in elderly living with sarcopenia/frailty but there are, to date, only few data available in the literature. First and foremost, it is crucial to understand the relationship between postprandial FGF-19 and muscle which has not been characterized yet.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Léo DELAIRE, MD
- Telefonní číslo: +33478363946
- E-mail: leo.delaire@chu-lyon.fr
Studijní záloha kontaktů
- Jméno: Hubert VIDAL, MD
- E-mail: hubert.vidal@univ-lyon1.fr
Studijní místa
-
-
-
Pierre-Bénite, Francie, 69495
- Aging Medicine Department / Hôpital Lyon Sud
-
Kontakt:
- Léo DELAIRE
- Telefonní číslo: +33478363946
- E-mail: leo.delaire@chu-lyon.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age ≥70 years
- Give his/her informed consent
- For the FRAIL group: SPPB ≤8, confirmed frailty (≥ 3 criteria in the Fried's appendix of frailty) and a at least a probable sarcopenia (regarding the revised European Working Group of Sarcopenia in Older People cut-offs ie. Low muscle strength either in the handgrip <27kg in men and <16kg in women or in the 5-repetitions chair stand test >15s)
- For the ROBUST group: SPPB >8, no frailty (no criterion in the Fried's appendix of frailty) and no sarcopenia (normal muscle strength regarding the European Working Group of Sarcopenia in Older People cut-offs).
Exclusion Criteria:
- Individuals who have undergone cholecystectomy, colectomy, or small bowel resection
- Individuals with diabetes undergoing oral treatment with metformin
- Body mass index >35 kg/m2
- Persons admitted to a health or social care facility for purposes other than research
- Persons not affiliated with a social security system or beneficiaries of a similar system
- Failure to comply with the exclusion period from another study specified in the national volunteer registry
- Adults subject to legal protection measures (guardian, curator)
- Persons deprived of their liberty by judicial or administrative decision
- Persons who have exceeded the annual compensation amount for participation in research protocols
- Persons with a chronic progressive or advanced disease detectable by clinical examination and laboratory tests that may interfere with the study's evaluation criteria, the judgment of which is left to the discretion of the research team
- Persons with hemiplegia or another form of partial/total paralysis
- Contraindications to metabolic testing: severe coagulation disorder, anemia, difficult and painful venous access in the investigator's judgment
- Chronic constipation or diarrhea
- Taking antibiotics within 15 days prior to the investigations and in the absence of induced digestive disorders (for so-called common antibiotics of the beta-lactam family) or within the month prior to the investigations, at the investigator's discretion (for Augmentin).
- Polypharmacy, including drugs known to affect the microbiota and intestinal transit
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Promítání
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: FRAIL
Older adult (>70 years) with a Short Physical Performance Battery (SPPB) score ≤8, confirmed frailty (≥ 3 criteria in the Fried's appendix of frailty) and a sarcopenia at least probable (regarding the revised European Working Group of Sarcopenia in Older People cut-offs ie. Low muscle strength either in the handgrip <27kg in men and <16kg in women or in the 5-repetitions chair stand test >15s) |
Following inclusion, participants will be summoned within 30 days maximum. They will be asked to fast from 8 pm the night before and will receive specific instructions for their last meal. Prior to blood sampling, they will be seen by a doctor who will rule-out any contraindications to the test. If conditions are met, a trained nurse will insert a venous catheter and the intravenous infusion required for blood sampling. An initial sample will be taken in the fasting state. Then, participants will have to eat a standardized meal consisting of a vegetable soup enriched with cream, palm and rapeseed oil, together with a vanilla cream enriched with glucose. The meal will provide a total of 921 kcal with 20.1g of protein, 59.6 of fat and 75g of carbohydrates in total. Following meal, blood will be collected each hour during 4 hours. Participant will remain under constant medical supervision. After sampling, doctor will ensure that participant does not show any negative clinical signs. |
|
Jiný: ROBUST
Older adult (>70 years) with a SPPB score >8, no frailty (no criterion in the Fried's appendix of frailty) and no sarcopenia (normal muscle strength regarding the European Working Group of Sarcopenia in Older People cut-offs). |
Following inclusion, participants will be summoned within 30 days maximum. They will be asked to fast from 8 pm the night before and will receive specific instructions for their last meal. Prior to blood sampling, they will be seen by a doctor who will rule-out any contraindications to the test. If conditions are met, a trained nurse will insert a venous catheter and the intravenous infusion required for blood sampling. An initial sample will be taken in the fasting state. Then, participants will have to eat a standardized meal consisting of a vegetable soup enriched with cream, palm and rapeseed oil, together with a vanilla cream enriched with glucose. The meal will provide a total of 921 kcal with 20.1g of protein, 59.6 of fat and 75g of carbohydrates in total. Following meal, blood will be collected each hour during 4 hours. Participant will remain under constant medical supervision. After sampling, doctor will ensure that participant does not show any negative clinical signs. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Area Under Curve (AUC) of plasmatic post-prandial FGF-19 level
Časové okno: 0 min, 60 min, 120min, 180min, 240min
|
Blood samples will be stocked at -80 degrees in the laboratory and will be analyzed by ELISA kits at the end of the inclusion period. |
0 min, 60 min, 120min, 180min, 240min
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 69HCL25_1186
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .