NCT07796932

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
38mo left

Started Jan 2027

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

3.1 years

First QC Date

July 22, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

neurological inflammationObesityCANTAB

Outcome Measures

Primary Outcomes (1)

  • Memory function characteristic

    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

Study Arms (1)

Magnetic Resonance Imaging, CANTAB questionnaires

Other: RMI and Questionnaires

Interventions

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.

Magnetic Resonance Imaging, CANTAB questionnaires

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Daniela COTA, Pr

    INSERM u1215

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

September 1, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share