Atherothrombosis Markers in Diabetics (MADI)
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ClinicalTrials.gov Identifier: NCT02898467 |
Recruitment Status : Unknown
Verified September 2016 by Centre Hospitalier Universitaire de la Réunion.
Recruitment status was: Not yet recruiting
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
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Condition or disease | Intervention/treatment |
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Diabetes Atherothrombosis Cardiovascular Disease | Other: diabetics Other: non-diabetics |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Comparison of Atherothrombosis Markers From Aortic Atheroma in Diabetic and Non-diabetic Patients |
Study Start Date : | October 2016 |
Estimated Primary Completion Date : | November 2018 |
Estimated Study Completion Date : | June 2019 |
Group/Cohort | Intervention/treatment |
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diabetics
Type 2 diabetic patients exhibiting fasting glycemia value over 7 mmol/L or glycated hemoglobin value over 6.5% or type 2 diabetic patients under oral anti-diabetic treatment or type 2 diabetic patient under insulin treatment and in which diabetes has been diagnosed after the age of 45 y
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Other: diabetics
additional blood and urine collection during usual medical care endarterectomy samples during usual medical care |
non-diabetics
patients without diagnosed diabetes exhibiting fasting glycemia value under 7 mmol/L
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Other: non-diabetics
additional blood and urine collection during usual medical care endarterectomy samples during usual medical care |
- Neutrophile activation assessed by free DNA levels in atherothrombotic plaques [ Time Frame: On day 1 (day of the surgery) ]Ability of cfDNA concentration in the conditioned medium to discriminate atherothrombotic plaques from diabetic vs non-diabetic patients
- Neutrophile activation assessed by other makers than free DNA levels in atherothrombotic plaques [ Time Frame: On day 1 (day of the surgery) ]Evaluation of PMN activation by assays other than cfDNA (myeloperoxidase, elastase/antielastase complexes, MMP9/neutrophil-gelatinase associated lipocalin NGAL) in the conditioned media and in plasma
- Intraplaque hemorrhage and oxidative stress assessed in plasma and aortic tissue [ Time Frame: From day 0 (day before the surgery) to day 1 (day of the surgery) ]Evaluation of markers reflecting the presence of intraplaque hemorrhage and of oxidative stress in conditioned medium and in plasma (CD163, heme, carbonylated proteins, glycated albumin...)
- Correlation between plasma and atherothrombotic plaque markers assessement [ Time Frame: From day 0 (day before the surgery) to day 1 (day of the surgery) ]Correlations between markers released by the plaque and plasma markers (evaluation of the impact of atherothrombosis at a circulating level)
- Atherothrombosis characterization assessed by histological analysis [ Time Frame: On day 1 (day of the surgery) ]Histological characterization of plaques assessed by quantification of neovessels, calcification, lipids composition
- Banking of biological samples [ Time Frame: From day 0 (day before the surgery) to day 1 (day of the surgery) ]Constitution of a biobank available for different assays of markers and for the discovery of new biomarkers of plaques in type 2 diabetic patients (open approaches, such as differential proteomics)
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adult patients with planned endarterectomy
- Affiliated to social security rights
- Signed inform consent
Exclusion Criteria:
- pregnancy
- Autoimmune disease, chronic inflammatory disease, neoplasia
- Type 1 diabetes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898467
Contact: CHRISTINE JUHEL, PHD | +262262359949 | christine.juhel@chu-reunion.fr |
France | |
Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site | |
Saint Denis de La Réunion, France, 97405 |
Principal Investigator: | XAVIER DEBUSSCHE, MD | CHU DE LA REUNION |
Responsible Party: | Centre Hospitalier Universitaire de la Réunion |
ClinicalTrials.gov Identifier: | NCT02898467 |
Other Study ID Numbers: |
2013/CHU/06 |
First Posted: | September 13, 2016 Key Record Dates |
Last Update Posted: | September 13, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Cardiovascular Diseases |