Carotid StenosisMASCADINCT03202823
Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients
An observational study of Carotid Stenosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Diabetes is associated with an increased risk of cardiovascular complications, as a reflection of the chronic inflammatory status. Monocytes-macrophages in diabetic subjects present impaired arachidonic acid metabolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- blood samples and recover samples of atheromatous plaque
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2017to 11 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic and non-diabetic patients with carotid stenosis who undergo surgery
Who may be able to join
- Patients who have provided explicit consent
- Patients older than 18 years
- Patients about to undergo surgery for carotid stenosis
- Haemoglobin ≥ 7g/dl at the time the sample is taken
- Respect the maximum volume of blood taken (treatment + research) in 30 days
- SPECIFIC TO DIABETICS
- Patients with type 1 or 2 diabetes diagnosed more than 6 months earlier
Who cannot join
- Patients under guardianship
- Patients without health insurance cover
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes is associated with an increased risk of cardiovascular complications, as a reflection of the chronic inflammatory status. Monocytes-macrophages in diabetic subjects present impaired arachidonic acid metabolism. Moreover, atheromatous plaques in diabetic subjects seem to be significantly enriched in 2-AA-LPC (2-arachidonoyl-lysophosphatidylcholine) and are more inflammatory and more likely to rupture than are plaques in non-diabetic subjects. We therefore hypothesize that this vulnerability of atheromatous plaques in diabetic subjects could be explained by impaired 2-AA-LPC metabolism within the plaque.
- Conditions
- Carotid Stenosis
- Being tested
- blood samples, recover samples of atheromatous plaque
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesProcedure or surgery
3 tubes (5 ml volume) collected during surgery
recover samples of atheromatous plaqueProcedure or surgery
a carotid sample collected during surgery
| Study group | Role | What they receive |
|---|---|---|
| Diabetics | Not described Receives: Procedure: blood samples; Procedure: recover samples of atheromatous plaque | |
| Non-diabetics | Not described Receives: Procedure: blood samples; Procedure: recover samples of atheromatous plaque |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arachidonic acid metabolism of atheromatous plaques from diabetic versus non-diabetic subjects
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start13 Apr 2017
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
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 Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202823
- Sponsor's protocol ID
- MENEGAUT 2016
- Acronym
- MASCADI
- Status last verified
- Feb 2026
- First submitted
- 21 Jun 2017
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Menegaut L, Laubriet A, Crespy V, Leleu D, Pilot T, Van Dongen K, de Barros JP, Gautier T, Petit JM, Thomas C, Nguyen M, Steinmetz E, Masson D. Inflammation and oxidative stress markers in type 2 diabetes patients with Advanced Carotid atherosclerosis. Cardiovasc Diabetol. 2023 Sep 14;22(1):248. doi: 10.1186/s12933-023-01979-1.
PubMed 37710315
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03202823
- Acronym / sponsor ID
- MASCADI / MENEGAUT 2016
- Conditions
- Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 29 Jun 2017 (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.
Diabetes is associated with an increased risk of cardiovascular complications, as a reflection of the chronic inflammatory status. Monocytes-macrophages in diabetic subjects present impaired arachidonic acid metabolism. Moreover, atheromatous plaques in diabetic subjects seem to be significantly enriched in 2-AA-LPC (2-arachidonoyl-lysophosphatidylcholine) and are more inflammatory and more likely to rupture than are plaques in non-diabetic subjects. We therefore hypothesize that this vulnerability of atheromatous plaques in diabetic subjects could be explained by impaired 2-AA-LPC metabolism within the plaque.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetics | – | Procedure: blood samples, Procedure: recover samples of atheromatous plaque |
| Non-diabetics | – | Procedure: blood samples, Procedure: recover samples of atheromatous plaque |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic and non-diabetic patients with carotid stenosis who undergo surgery
Key inclusion criteria (7 listed)
- Patients who have provided explicit consent
- Patients older than 18 years
- Patients about to undergo surgery for carotid stenosis
- Haemoglobin ≥ 7g/dl at the time the sample is taken
- Respect the maximum volume of blood taken (treatment + research) in 30 days
Key exclusion criteria (3 listed)
- Patients under guardianship
- Patients without health insurance cover
- Pregnant or breast-feeding women
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 samples3 tubes (5 ml volume) collected during surgery | Procedure or surgery | Diabetics, Non-diabetics |
| recover samples of atheromatous plaquea carotid sample collected during surgery | Procedure or surgery | Diabetics, Non-diabetics |
Primary outcome
Change in arachidonic acid metabolism of atheromatous plaques from diabetic versus non-diabetic subjects
Time frame: Baseline
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 Feb 2026.
- Results publication: PubMed 37710315Menegaut L, Laubriet A, Crespy V, Leleu D, Pilot T, Van Dongen K, de Barros JP, Gautier T, Petit JM, Thomas C, Nguyen M, Steinmetz E, Masson D. Inflammation and oxidative stress markers in type 2 diabetes patients with Advanced Carotid atherosclerosis. Cardiovasc Diabetol. 2023 Sep 14;22(1):248. doi: 10.1186/s12933-023-01979-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carotid Stenosis, run by Centre Hospitalier Universitaire Dijon 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 7 inclusion and 3 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 Feb 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?
Change in arachidonic acid metabolism of atheromatous plaques from diabetic versus non-diabetic subjects (time frame: Baseline). 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 NCT03202823, 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 Feb 2026.