Circulating pyrophosphate as a marker of vascular calcification in type 2 diabetes

Role of Circulating Pyrophosphate as a Biomarker of Mediacalcinosis in Type 2 Diabetic Patients

This project will see if blood levels of inorganic pyrophosphate (PPi) can indicate peripheral vessel calcification in men aged 40–70 with type 2 diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 70 Years
• Sex: Male
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Locations: 1 site (Nice, France)
• Trial ID: NCT07005986 on ClinicalTrials.gov

What this trial studies

This is a single-center pilot study at CHU de Nice measuring plasma PPi in adult men with type 2 diabetes. Investigators will also measure ENPP1 activity and alkaline phosphatase (ALP) to explore mechanisms that could alter PPi levels. PPi and enzyme results will be compared with clinical features and evidence of peripheral vascular calcification and cardiovascular risk factors. The aim is to determine whether lower circulating PPi is linked to mediacalcosis in this patient group and could serve as a blood marker.

Who should consider this trial

Good fit: Men aged 40–70 with type 2 diabetes who are treated with at least one SGLT2 inhibitor and are covered by French social security, living in Alpes-Maritimes or Var, are the intended participants.

Not a fit: Women, patients outside the 40–70 age range, those living outside Alpes-Maritimes or Var, people without French social security coverage, or those with severe kidney failure are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, measuring PPi could provide a simple blood test to identify diabetic patients at higher risk of vascular calcification and help guide preventive care.

How similar studies have performed: Laboratory and observational work supports PPi as a natural anti-calcifier and links ENPP1/ALP changes to insulin resistance, but using plasma PPi as a clinical biomarker in type 2 diabetes remains largely untested.

Eligibility criteria

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.

Where this trial is running

Nice, France

• CHU de Nice — Nice, France, France (Recruiting)

Study contacts

• Study coordinator: Nicolas NC Chevalier, Professor

Conditions Type 2 Diabetes; Type 2 Diabetes Patients; Type 2 diabetes