Type 2 Diabetes, Type 2 Diabetes Patients
Conditions
Keywords
Type 2 diabetes
Brief summary
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.
Interventions
DIAGNOSTIC_TESTPlasmatic PPi level
Plasmatic PPi level dosage at visit 1
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Adult men (between 40 and 70 years of age). 2. T2DM defined according to ADA or HAS criteria, evolving for more than 6 months, may be : - Not complicated * Complicated by diabetic retinopathy and/or diabetic nephropathy (creatinine clearance \> 60 ml/min) and/or peripheral arterial disease and/or ischemic heart disease and/or stroke. - With dyslipidemia (LDLc \> 1.90) and/or a history of past or active smoking. * Balanced with HbA1c \< 8% according to patient's personalized objectives, or unbalanced with HbA1c \> 9%. * Treated with insulin therapy (single or multi-injections) or not. - Whose treatment includes at least one iSGLT2. 3. Member of 'Sécurité Sociale
Exclusion criteria
1. Patient already included in another study. 2. Patient in a particular situation judged incompatible with the study by the investigator. 3. Patient living in a department other than Alpes-Maritimes or Var. 4. Patient refusing to give consent. 5. Patient deprived of liberty by administrative or judicial decision, under guardianship or curatorship. 6. Patient with decompensated hepatic cirrhosis (Child C and above, score 10 to 15 points). 7. Patients with chronic kidney disease (from stage 3, i.e. GFR \< 59 ml/min/1.73 m2). 8. Patient with a recent fracture (within the last 3 months). 9. Patient treated with AVK or biphosphonates. 10. Patient with known, treated osteoporosis. 11. Patient with unsupplemented vitamin D deficiency. 12. Patient with active cancer. 13. Patient with an active inflammatory pathology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of plasma inorganic pyrophosphate level | Blood samples are taken during first visit, in the morning, after fasting | Measurement of plasma inorganic pyrophosphate level in Type 2 diabetes patients and comparaison with a laboratory reference value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coronary and lower limb calcification score | The Computed tomography scan will be performed within two weeks after fisrt visit | The coronary and lower limb calcification score will be determined using a non-contrast Computed tomography scan of the coronary arteries and lower limbs |
Countries
France
Contacts
Primary ContactNicolas NC Chevalier, Professor
Backup ContactMarion CAUSERET
Outcome results
None listed