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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Registry Identifier | 2025-A00626-43 |
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Type 2 diabetes currently affects around 4 million people in France, with the number of cases rising steadily. Complications of T2DM are essentially cardiovascular. In particular, T2DM is associated with calcification of peripheral vessel walls (mediacalcosis), responsible for increased vascular stiffness. This calcium deposition is known to be a cardiovascular risk factor, but the mechanism of its deposition in relation to diabetes is not clearly established. An important blood compound, inorganic pyrophosphate (PPi), which is the body's natural anti-calcifier is impacted in some way in T2DM. PPi is degraded by alkaline phosphatase (ALP), and is produced by an enzyme called ENPP1. ENPP1 activity is decreased and APL activity increased in insulin-resistant subjects, which could contribute to a decrease in tissue and circulating PPi, and thus favor a tissue pro-calcifying balance. We propose to test this hypothesis in a pilot study characterizing plasma PPi levels, in relation to ENPP1 activity, in type 2 diabetic patients. The aim of the study is also to determine if there is a link between blood PPi levels and the progression of calcifications in arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasmatic PPi level, ENPI level and CT-scan of coronary arteries and lower limbs arteries | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmatic PPi level | Diagnostic Test | Plasmatic PPi level dosage at visit 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of plasma inorganic pyrophosphate level | Measurement of plasma inorganic pyrophosphate level in Type 2 diabetes patients and comparaison with a laboratory reference value | Blood samples are taken during first visit, in the morning, after fasting |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary and lower limb calcification score | The coronary and lower limb calcification score will be determined using a non-contrast Computed tomography scan of the coronary arteries and lower limbs | The Computed tomography scan will be performed within two weeks after fisrt visit |
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Inclusion Criteria:
Adult men (between 40 and 70 years of age).
T2DM defined according to ADA or HAS criteria, evolving for more than 6 months, may be : - Not complicated
Member of 'Sécurité Sociale"
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas NC Chevalier, Professor | Contact | 0492034702 | causeret.m@chu-nice.fr | |
| Marion CAUSERET | Contact | +33492034702 | causeret.m@chu-nice.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Recruiting | Nice | France | 06000 | France |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |