- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07557628
Studie der hypothalamischen Mikroglia-Reaktion als Funktion des Lipidgehalts einer Mahlzeit bei Menschen. Eine monozentrische prospektive Kohortenstudie bei gesunden männlichen Probanden (GLIPID)
Studie der hypothalamischen Mikroglia-Reaktion als Funktion des Lipidgehalts einer Mahlzeit beim Menschen. Eine monozentrische prospektive Kohortenstudie an gesunden männlichen Probanden
Obesity and its complications represent a growing public health problem in our society. A better understanding of the biological mechanisms involved in regulating food intake-and, more broadly, energy metabolism-should lead to improved management of this condition.
Recent studies have shown that eating a single meal can rapidly trigger the activation of the immune system. This leads to a postprandial, systemic, and transient inflammatory response (Emerson SR, Adv Nutr 2017). It is found in both healthy and obese individuals. It has also been observed in rodents, enabling preclinical studies to better understand the phenomenon. This postprandial inflammation is characterized by the activation of macrophages in the gastrointestinal tract and by elevated levels of circulating pro-inflammatory markers. At the cellular level, nutrients activate an intracellular molecular sensor called the inflammasome, which is a multiprotein complex formed by the oligomerization of proteins including NLRP3 (Nod-like receptors pyrin domain-containing 3) and ASC (Apoptosis-associated Speck-like protein containing a CARD domain). This sensor activates caspase 1, an enzyme that converts pro-interleukin 1β (pro-IL-1β) into its mature and active form, IL-1β. This molecular mechanism converts the nutritional signal into an immune response.
Under physiological conditions, this acute response appears to have beneficial effects on the body. Indeed, it plays a positive role in blood glucose control by stimulating insulin secretion and glucose utilization (Dror, Nat Immunol 2017). However, in the context of chronic overeating and excessive consumption of saturated fats and simple sugars, this systemic inflammation becomes harmful, promoting adipocyte hypertrophy, insulin resistance, hepatic steatosis, and vascular damage (Hotamisligil, Nature 2017).
In mice, our team recently demonstrated the existence of a postprandial inflammatory response in the central nervous system (Cansell, Glia 2021). This response occurs specifically in the hypothalamus, a brain structure involved in regulating food intake and controlling energy metabolism. It is characterized by microglial reactivity visible as early as 3 hours after the start of the postprandial phase. This postprandial microglial activation occurs after the ingestion of a high-fat meal, whereas it is rarely or never observed after the ingestion of a standard balanced meal. It is characterized by a morphological change in hypothalamic microglia, including an increase in the length of microglial processes and their branching. This gliosis is associated with increased expression of IL-1β in microglial cells. Thus, the postprandial gliosis observed 3 hours after a high-fat meal is inflammatory. Using a targeted genetic approach that allows for the ablation of the inflammasome in microglial cells, the team demonstrates that postprandial gliosis exerts a satiating effect, limiting subsequent food intake following a high-calorie, high-fat meal. Thus, microglial inflammation appears to be an additional component in the body's arsenal of adaptive homeostatic responses aimed at limiting energy intake.
Our clinical project will involve translating our basic findings in mice to humans. This will involve investigating postprandial hypothalamic gliosis in the human brain following a standard meal or a high-fat meal. The initial studies will be conducted exclusively in healthy male subjects to avoid the influence of the hormonal cycle on the hypothalamic response. The impact of physiological aging on the hypothalamic microglial inflammatory response will also be taken into account.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Vincent SCHNEIDER
- Telefonnummer: +33 03 80 29 30 89
- E-Mail: vincent.schneider@chu-dijon.fr
Studienorte
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Dijon, Frankreich, 21000
- Rekrutierung
- Chu Dijon Bourgogne
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Kontakt:
- Vincent SCHNEIDER
- Telefonnummer: +33 03 80 29 30 89
- E-Mail: vincent.schneider@chu-dijon.fr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Healthy male volunteers
Beschreibung
Inclusion Criteria:
- A person who has given oral consent
- Male
- Body Mass Index (BMI) between 18.5 and 30 kg/m²
- Age ≥ 20 years
Exclusion Criteria:
- A person subject to a measure of legal protection (guardianship, tutorship)
- A person subject to a judicial protective measure
- A person who is not enrolled in or eligible for a social security program
- Subject does not speak French
- Subjects with a pacemaker or any other contraindication to MRI
- Subjects with type 1 or type 2 diabetes
- Subjects with a chronic inflammatory condition
- Subjects with a neuropsychiatric condition
- Subjects taking anti-inflammatory medication or medication that affects the central nervous system
- Known hypersensitivity to foods provided during the study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Male subjects
Healthy volunteers to study the biological mechanisms that control food intake and energy metabolism |
Hormone and metabolic tests (insulin, IGF-1, leptin, blood glucose, ghrelin) Measurement of the T1 and T2 relaxation times in the hypothalamic region Eating habits and preferences Measurements of lean body mass, fat mass, body water and bone mass |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The difference in hypothalamic MRI signal intensity between the baseline state and the postprandial state observed after a balanced meal and after a high-fat meal for each subject.
Zeitfenster: 2 days
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Measurement of hypothalamic T2 relaxation time |
2 days
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Untersuchungstechniken
- Epidemiologische Methoden
- Handhabung von Proben
- Klinische Labortechniken
- Diagnosetechniken und Verfahren
- Diagnose
- Punktionen
- Chirurgische Eingriffe, operativ
- Pharmakologische Maßnahmen
- Chemische Handlungen und Verwendung
- Datenerfassung
- Gesundheitsbewertungsmechanismen
- Qualität der Gesundheitsversorgung
- Öffentliche Gesundheit
- Umwelt und öffentliche Gesundheit
- Spezialzwecke von Chemikalien
- Physiologisches Verdauungssystem physiologische Phänomene
- Verdauungssystem und orale physiologische Phänomene
- Diagnostische Anwendungen von Chemikalien
- Umfragen und Fragebögen
- Blutprobensammlung
- Kontrastmedien
- Postprandiale Periode
Andere Studien-ID-Nummern
- SCHNEIDER 2025
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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