ObesityODCOTANCT04907565
Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
An observational study of Obesity and Cognitive Impairment, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Obesity, Cognitive Impairment, Post-Operative Confusion
- What is being tested?
- Blood sampling and white adipose tissue sampling
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2021to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: prospective, monocentric study conduct in Toulouse university hospital
Who may be able to join
- 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
Who cannot join
- emergency surgery, or surgery in a septic context,
- patient with a known dementia or altered MMSE score (under 20)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Cognitive Impairment, Post-Operative Confusion
- Being tested
- Blood sampling, white adipose tissue sampling
- Keywords
- Obesity, Post-operative cognitive dysfunction, Inflammation, Inflammatory cytokines
- Medical subject headings
- Obesity, Cognitive Dysfunction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
4 tubes of 7 mL of blood will be collected
white adipose tissue samplingBiological
At the beginning of the surgery, samples of white adipose tissue from the surgical wound will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | BMI >30kg/m2 Receives: Biological: Blood sampling; Biological: white adipose tissue sampling | |
| non obese patients | BMI between 18 to 29kg/m2 Receives: Biological: Blood sampling; Biological: white adipose tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 5 after surgery
Secondary outcomes (3)
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.
Measured: Day 0 and day 5 after surgery
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
Measured: day 5 after surgery
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).
Measured: day 5 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start21 Sep 2021
- Primary completion30 Sep 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Labaste, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907565
- Sponsor's protocol ID
- RC31/21/0014
- Acronym
- ODCOTA
- Status last verified
- Mar 2026
- First submitted
- 25 May 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pey V, Stephan M, Gros P, Dray C, Bounes F, Marcheix B, Minville V, Galinier A, Labaste F. Assessment of arterial whole blood redox potential during cardiopulmonary bypass. PLoS One. 2025 May 27;20(5):e0324437. doi: 10.1371/journal.pone.0324437. eCollection 2025.
PubMed 40424308
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
- ClinicalTrials.gov ID
- NCT04907565
- Acronym / sponsor ID
- ODCOTA / RC31/21/0014
- Conditions
- Obesity, Cognitive Impairment, Post-Operative Confusion
- Keywords
- Obesity, Post-operative cognitive dysfunction, Inflammation, Inflammatory cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Biological: Blood sampling, Biological: white adipose tissue samplingBMI >30kg/m2 |
| non obese patients | – | Biological: Blood sampling, Biological: white adipose tissue samplingBMI between 18 to 29kg/m2 |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prospective, monocentric study conduct in Toulouse university hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- emergency surgery, or surgery in a septic context,
- patient with a known dementia or altered MMSE score (under 20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling4 tubes of 7 mL of blood will be collected | Biological | Obese patients, non obese patients |
| white adipose tissue samplingAt the beginning of the surgery, samples of white adipose tissue from the surgical wound will be collected. | Biological | Obese patients, non obese patients |
Primary outcome
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.
3 secondary outcomes
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
Identification of a linked between inflammatory cytokine levels and the appearance of POCD.
Time frame: day 5 after surgery
Peri-operative variations of the protein S100B, an autonomy scale (IADL) and a quality of life scale (EQ5D).
Time frame: day 5 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Results publication: PubMed 40424308Pey V, Stephan M, Gros P, Dray C, Bounes F, Marcheix B, Minville V, Galinier A, Labaste F. Assessment of arterial whole blood redox potential during cardiopulmonary bypass. PLoS One. 2025 May 27;20(5):e0324437. doi: 10.1371/journal.pone.0324437. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Labaste, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Cognitive Impairment, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arising of POCD measured by a composite criterion (time frame: day 5 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04907565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.