Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients (MASCADI)

January 25, 2021 updated by: Centre Hospitalier Universitaire Dijon
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetics
Procedure: blood samples
3 tubes (5 ml volume) collected during surgery
Procedure: recover samples of atheromatous plaque
a carotid sample collected during surgery
Non-diabetics
Procedure: blood samples
3 tubes (5 ml volume) collected during surgery
Procedure: recover samples of atheromatous plaque
a carotid sample collected during surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2017

Primary Completion (Actual)

December 11, 2020

Study Completion (Actual)

December 11, 2020

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MENEGAUT 2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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