- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04907565
Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue (ODCOTA)
March 5, 2026 updated by: University Hospital, Toulouse
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
115
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France, 31059
- Purpan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
prospective, monocentric study conduct in Toulouse university hospital
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Obese patients
BMI >30kg/m2
|
4 tubes of 7 mL of blood will be collected
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
|
4 tubes of 7 mL of blood will be collected
At the beginning of the surgery, samples of white adipose tissue from the surgical wound will be collected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
day 5 after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Day 0 and day 5 after surgery
|
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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
|
day 5 after surgery
|
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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).
|
day 5 after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: François Labaste, MD, PhD, University Hospital, Toulouse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2021
Primary Completion (Actual)
September 30, 2024
Study Completion (Actual)
March 30, 2025
Study Registration Dates
First Submitted
May 25, 2021
First Submitted That Met QC Criteria
May 25, 2021
First Posted (Actual)
May 28, 2021
Study Record Updates
Last Update Posted (Actual)
March 9, 2026
Last Update Submitted That Met QC Criteria
March 5, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nutrition Disorders
- Overnutrition
- Body Weight
- Neurocognitive Disorders
- Cognition Disorders
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Cognitive Dysfunction
- Inflammation
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- RC31/21/0014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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