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

Obesity Clinical Trial

— ODCOTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907565
• Other study ID #: RC31/21/0014
• Status: Recruiting
• Start date: September 21, 2021
• Est. completion date: September 21, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Toulouse
• Contact: François Labaste, MD, PhD
• Phone: 561322822
• Email: labaste.f[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: September 21, 2025
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Confusion
• Obesity
• Post-Operative Confusion
• Postoperative Cognitive Complications

Intervention

Biological:
• Blood sampling
4 tubes of 7 mL of blood will be collected
• white adipose tissue sampling
At the beginning of the surgery, samples of white adipose tissue from the surgical wound will be collected.

Locations

Country	Name	City	State
France	Purpan University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Variation of inflammatory cytokine levels from patient's plasma and patient's white adipose tissue (extract from a controlled medium).	inflammatory cytokine levels will be measured in plasma and adipose tissue, and compared.	Day 0 and day 5 after surgery
Secondary	Identification of a linked between inflammatory cytokine levels and the appearance of POCD.	inflammatory cytokine levels will be measured in plasma and adipose tissue, and correlated with appearance of POCD	day 5 after surgery
Secondary	Peri-operative variations of the protein S100B, an autonomy scale (IADL) and a quality of life scale (EQ5D).	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).	day 5 after surgery