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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Nice
  Nice, France, France Recruiting

Study contacts

• Study coordinator: Nicolas NC Chevalier, Professor
• Email: causeret.m@chu-nice.fr
• Phone: 0492034702

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.