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

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04907565
• Collaborator: (none)
• Enrollment: 408
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 17

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Cognitive Impairment; Post-Operative Confusion	Biological: Blood sampling; Biological: white adipose tissue sampling

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 Design

• Study Type: Observational
• Anticipated Enrollment: 408 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
• Actual Study Start Date: May 21, 2021
• Anticipated Primary Completion Date: May 21, 2022
• Anticipated Study Completion Date: May 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Obese patients BMI >30kg/m2	Biological: Blood sampling; 4 tubes of 7 mL of blood will be collected; Biological: white adipose tissue sampling; At the beginning of the surgery, samples of white adipose tissue from the surgical wound will be collected.
non obese patients BMI between 18 to 29kg/m2	Biological: Blood sampling; 4 tubes of 7 mL of blood will be collected; Biological: white adipose tissue sampling; At the beginning of the surgery, samples of white adipose tissue from the surgical wound will be collected.

Outcome Measures

Primary Outcome Measures

1. 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 CAM during the hospital course.

Secondary Outcome Measures

1. 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.

2. 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

3. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patient of 60 years old at least,

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Purpan University Hospital	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

• Principal Investigator: François Labaste, MD, PhD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT04907565
• Other Study ID Numbers: RC31/21/0014
• First Posted: May 28, 2021
• Last Update Posted: Jul 9, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Toulouse: Obesity; Post-operative cognitive dysfunction; Inflammation; Inflammatory cytokines
• Additional relevant MeSH terms: Confusion; Obesity; Postoperative Cognitive Complications; Cognitive Dysfunction

Study Results

No Results Posted as of Jul 9, 2021