NCT04907565

Brief Summary

This research aims at describing the relationship between white adipose tissue inflammation and post-operative cognitive dysfunctions.The possible link between inflammatory cytokines secretions of the white adipose tissue of a surgical wound and the arising of patient's cognitive dysfunction in the post-operative course will be investigated. The hypothesis is that obese patient's inflammation of the white adipose tissue leads to cognitive dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

May 25, 2021

Last Update Submit

March 5, 2026

Conditions

ObesityCognitive ImpairmentPost-Operative Confusion

Keywords

ObesityPost-operative cognitive dysfunctionInflammationInflammatory cytokines

Outcome Measures

Primary Outcomes (1)

  • Arising of POCD measured by a composite criterion

    2 points Mini-Mental State Examination (MMSE) score decrease compared to the pre-operative score, and/or appearance of a delirium tracked down every day by the Confusion Assessment Method (CAM) during the hospital course.

    day 5 after surgery

Secondary Outcomes (3)

  • Variation of inflammatory cytokine levels from patient's plasma and patient's white adipose tissue (extract from a controlled medium).

    Day 0 and day 5 after surgery

  • Identification of a linked between inflammatory cytokine levels and the appearance of POCD.

    day 5 after surgery

  • Peri-operative variations of the protein S100B, an autonomy scale (IADL) and a quality of life scale (EQ5D).

    day 5 after surgery

Study Arms (2)

Obese patients

BMI \>30kg/m2

Biological: Blood samplingBiological: white adipose tissue sampling

non obese patients

BMI between 18 to 29kg/m2

Biological: Blood samplingBiological: white adipose tissue sampling

Interventions

Blood samplingBIOLOGICAL

4 tubes of 7 mL of blood will be collected

Obese patientsnon obese patients
white adipose tissue samplingBIOLOGICAL

At the beginning of the surgery, samples of white adipose tissue from the surgical wound will be collected.

Obese patientsnon obese patients

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

prospective, monocentric study conduct in Toulouse university hospital

You may qualify if:

  • patient about to receive a hip arthroplasty under general anesthesia, elective cardiac surgery with cardiopulmonary bypass,
  • patient with a MMSE score \> or = 20(/30),
  • patient able to give informed consent

You may not qualify if:

  • emergency surgery, or surgery in a septic context,
  • patient with a known dementia or altered MMSE score (under 20)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purpan University Hospital

Toulouse, 31059, France

Location

Related Publications (1)

  • Pey V, Stephan M, Gros P, Dray C, Bounes F, Marcheix B, Minville V, Galinier A, Labaste F. Assessment of arterial whole blood redox potential during cardiopulmonary bypass. PLoS One. 2025 May 27;20(5):e0324437. doi: 10.1371/journal.pone.0324437. eCollection 2025.

    PMID: 40424308RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and white adipose tissues

MeSH Terms

Conditions

ObesityCognitive DysfunctionInflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersPathologic Processes

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • François Labaste, MD, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

September 21, 2021

Primary Completion

September 30, 2024

Study Completion

March 30, 2025

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)