NCT07005986Recruiting
Role of Circulating Pyrophosphate as a Biomarker of Mediacalcinosis in Type 2 Diabetic Patients
Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 19 May 2025
- Start date
- 18 Jun 2025
- Primary completion date
- 18 Jul 2026
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Type 2 diabetes
- NCT number
- NCT07005986
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 18 Jun 2025 to the primary completion date, 18 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient treated with AVK or biphosphonates.
Other illness
- Patient with active cancer.
Lab values
- Patients with chronic kidney disease (from stage 3, i.e. GFR \< 59 ml/min/1.73 m2).
Other
- Patient already included in another study.
- Patient in a particular situation judged incompatible with the study by the investigator.
- Patient living in a department other than Alpes-Maritimes or Var.
- Patient refusing to give consent.
- Patient deprived of liberty by administrative or judicial decision, under guardianship or curatorship.
- Patient with decompensated hepatic cirrhosis (Child C and above, score 10 to 15 points).
- Patient with a recent fracture (within the last 3 months).
- Patient with known, treated osteoporosis.
- Patient with unsupplemented vitamin D deficiency.
- Patient with an active inflammatory pathology.
Who the study is looking for
- 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
- 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.
- Member of 'Sécurité Sociale"
Age in the registry: 40 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.