Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue

Recruiting

• Conditions: Obesity; Cognitive Impairment; Post-Operative Confusion
• Interventions: Biological: Blood sampling; Biological: white adipose tissue sampling

• Registration Number: NCT04907565
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

The postoperative cognitive dysfunctions (POCD) are characterized by delirium and cognitive impairment. The delirium is defined by an acute altered attention with a fluctuating course. The post-operative cognitive impairment involves the early alteration of different functions including memory, attention and cognitive flexibility. POCD have a major impact in patient's morbidity. They are linked to the systemic inflammation induced by the surgical wound. The systemic inflammation leads to the rupture of the brain-blood barrier and to hippocampal inflammation. As hippocampus mediates the principal cognitive functions, hippocampal inflammation leads to POCD. Orthopedic and cardiac surgery are particularly concerned. Obesity is growing condition in the French population. It is linked to chronic systemic inflammation and altered cognitive functions. We think that obese people may present a susceptibility to POCD because of the pre-operative systemic inflammation.

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2021-09-21
• Primary Completion: 2024-09-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Study Completion: 2025-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients	Blood sampling	BMI \>30kg/m2
non obese patients	Blood sampling	BMI between 18 to 29kg/m2
Obese patients	white adipose tissue sampling	BMI \>30kg/m2
non obese patients	white adipose tissue sampling	BMI between 18 to 29kg/m2

Primary Outcome Measures

Name	Time	Method
Arising of POCD measured by a composite criterion	day 5 after surgery	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.

Secondary Outcome Measures

Name	Time	Method
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	inflammatory cytokine levels will be measured in plasma and adipose tissue, and compared.
Identification of a linked between inflammatory cytokine levels and the appearance of POCD.	day 5 after surgery	inflammatory cytokine levels will be measured in plasma and adipose tissue, and correlated with appearance of POCD
Peri-operative variations of the protein S100B, an autonomy scale (IADL) and a quality of life scale (EQ5D).	day 5 after surgery	protein S100B levels will be measured in plasma and adipose tissue, and correlated with scores of autonomy scale (IADL) and quality of life scale (EQ5D).

Trial Locations

Locations (1)

Purpan University Hospital; 🇫🇷 Toulouse, France