Actively Recruiting
Role of Circulating Pyrophosphate as a Biomarker of Mediacalcinosis in Type 2 Diabetic Patients
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-07-10
20
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Role of Circulating Pyrophosphate as a Biomarker of Mediacalcinosis in Type 2 Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men between 40 and 70 years of age
- Diagnosed with type 2 diabetes for more than 6 months according to ADA or HAS criteria
- Type 2 diabetes may be uncomplicated or complicated by diabetic retinopathy, diabetic nephropathy (creatinine clearance > 60 ml/min), peripheral arterial disease, ischemic heart disease, or stroke
- May have dyslipidemia (LDLc > 1.90) and/or a history of past or current smoking
- Diabetes may be balanced with HbA1c < 8% or unbalanced with HbA1c > 9%
- Treated with insulin therapy (single or multiple injections) or not
- Treatment includes at least one iSGLT2 medication
- Member of 'Sécurité Sociale'
You will not qualify if you...
- Already participating in another study
- Considered incompatible with the study by the investigator
- Living outside Alpes-Maritimes or Var departments
- Refusing to give consent
- Deprived of liberty by administrative or judicial decision, under guardianship or curatorship
- Decompensated hepatic cirrhosis (Child C and above, score 10 to 15 points)
- Chronic kidney disease from stage 3 (GFR < 59 ml/min/1.73 m2)
- Recent bone fracture within the last 3 months
- Treated with AVK or biphosphonates
- Known and treated osteoporosis
- Vitamin D deficiency without supplementation
- Active cancer
- Active inflammatory disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Nice
Nice, France, France, 06000
Actively Recruiting
Research Team
N
Nicolas NC Chevalier, Professor
CONTACT
M
Marion CAUSERET
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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