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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the role of a substance in the blood called inorganic pyrophosphate (PPi) in relation to a condition called medial calcinosis in men with type 2 diabetes. Medial calcinosis happens when calcium builds up in the walls of blood vessels, which can increase the risk of heart problems. Researchers want to see if the levels of PPi in the blood, which normally helps keep calcium in check, are linked to the amount of calcification in the arteries of patients with type 2 diabetes.

To participate in this study, you need to be a man aged between 40 and 70 years who has been diagnosed with type 2 diabetes for at least six months. You can have diabetes with or without complications, and your treatment must include a specific type of medication called iSGLT2. Participants can expect to have their blood tested to measure PPi levels and other relevant factors. It's important to note that some individuals may not be eligible if they have certain health conditions or are currently involved in other studies.

Gender

MALE

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.