NCT03202823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

June 21, 2017

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in arachidonic acid metabolism of atheromatous plaques from diabetic versus non-diabetic subjects

    Baseline

Study Arms (2)

Diabetics

Procedure: blood samplesProcedure: recover samples of atheromatous plaque

Non-diabetics

Procedure: blood samplesProcedure: recover samples of atheromatous plaque

Interventions

blood samplesPROCEDURE

3 tubes (5 ml volume) collected during surgery

DiabeticsNon-diabetics

a carotid sample collected during surgery

DiabeticsNon-diabetics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 29, 2017

Study Start

April 13, 2017

Primary Completion

December 11, 2020

Study Completion

December 11, 2020

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations