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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03202823
Other study ID # MENEGAUT 2016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 13, 2017
Est. completion date December 11, 2020

Study information

Verified date January 2021
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date December 11, 2020
Est. primary completion date December 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
blood samples
3 tubes (5 ml volume) collected during surgery
recover samples of atheromatous plaque
a carotid sample collected during surgery

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in arachidonic acid metabolism of atheromatous plaques from diabetic versus non-diabetic subjects Baseline
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