- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07796932
Characterisation of MNEsic Involvement in Patients With Obesity. (MNEMOB)
The aim of the study is therefore to characterise memory impairment in a middle-aged population with obesity and to clarify the role of inflammation in obesity-related memory impairment.
The hypothesise that, as in an elderly population, neurological and memory impairment in a population of middle-aged obese individuals is heterogeneous, with varying levels of memory impairment characterised by neuropsychological test results. This heterogeneity in neuropsychological tests may be linked to markers of inflammation and brain imaging biomarkers identified previously in the litterature.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Blandine GATTA-CHERIFI, Pr
- Telefonnummer: +33 05 24 54 93 41
- E-mail: blandine.gatta-cherifi@chu-bordeaux.fr
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Recruitment will take place within the Specialised Obesity Centre at Bordeaux University Hospital.
As part of their obesity treatment within the department, new patients first attend a consultation, after which they are usually admitted for a five-day educational programme to undergo a comprehensive initial multidisciplinary assessment (covering medical, dietary, psychological, physical activity and social aspects).
Beskrivelse
Inclusion Criteria:
- Patients suffering from obesity with a BMI between 30 and 45 kg/m²
- Patients aged between 30 and 50 receiving educational care during the week at the CSO (Endocrinology, Diabetology and Nutrition Department) of the Bordeaux University Hospital.
- Right-handed patients
- Persons affiliated with or beneficiaries of a social security scheme.
- Free, informed and express consent
Exclusion Criteria:
- Patients currently undergoing treatment with neuroleptics or who have stopped treatment within the last 3 months.
- Pregnant or breastfeeding patients
- Known current or past neurological disease
- Proven depressive syndrome treated
- Patients with type 1 or type 2 diabetes
- Uncontrolled dysthyroidism
- MMS< 25
- Patients with proven genetic obesity
- Contraindication to MRI
- Chronic use of NSAIDs or corticosteroids
- Loss of 5% of body weight in the 3 months prior to the study
- Acute infection
- Persons deprived of their liberty by judicial or administrative decision
- Adults subject to legal protection measures (guardianship, curatorship, judicial protection)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Magnetic Resonance Imaging, CANTAB questionnaires
|
Magnetic resonance imaging (MRI) will collect anatomical information (3D T1 weighted images) to compute the volumes of the hypothalamus, hippocampus and the other brain parcels. Executive functions using the CANTAB tests and validated questionnaires will be performed. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Memory function characteristic
Tidsramme: 37 months after inclusion day
|
The main objective is to characterise memory function in a population of middle-aged individuals suffering from obesity using the CANTAB Paired Associates Learning (PAL) test.
|
37 months after inclusion day
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Daniela COTA, Pr, INSERM u1215
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Overernæring
- Kropsvægt
- Overvægtig
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fedme
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Undersøgelser og spørgeskemaer
Andre undersøgelses-id-numre
- CHUBX 2025/068
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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