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Completed

NCT Number: NCT04907565

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sampling

Biological

4 tubes of 7 mL of blood will be collected

white adipose tissue sampling

Biological

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

Primary outcomes

  1. Arising of POCD measured by a composite criterion

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: ODCOTA

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
May 28, 2021
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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