Arachidonic Acid Metabolism in Carotid Stenosis Plaque in... | NCT03202823

Studies
Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients

NCT03202823

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 9, 2026Actual

Enrollment

204Actual

Phase

Not provided

Conditions

Carotid Stenosis

Interventions

blood samples
recover samples of atheromatous plaque

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2017Actual

Primary Completion Date

Dec 11, 2020Actual

Completion Date

Dec 11, 2020Actual

First Submitted Date

Jun 21, 2017

First Submission Date that Met QC Criteria

Jun 26, 2017

First Posted Date

Jun 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

204Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetics			Procedure: blood samples Procedure: recover samples of atheromatous plaque
Non-diabetics			Procedure: blood samples Procedure: recover samples of atheromatous plaque

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood samples	Procedure	3 tubes (5 ml volume) collected during surgery	Diabetics Non-diabetics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in arachidonic acid metabolism of atheromatous plaques from diabetic versus non-diabetic subjects		Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients under guardianship
Patients without health insurance cover
Pregnant or breast-feeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diabetic and non-diabetic patients with carotid stenosis who undergo surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourgogne		Dijon		21000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37710315	Result	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.

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis