- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Blandine GATTA-CHERIFI, Pr
- Phone Number: +33 05 24 54 93 41
- Email: blandine.gatta-cherifi@chu-bordeaux.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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).
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory function characteristic
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Daniela COTA, Pr, INSERM u1215
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- CHUBX 2025/068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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