Role of Circulating Pyrophosphate as a Biomarker of Mediacalcinosis in Type 2 Diabetic Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-70
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Plasmatic PPi level
Diagnostic testPlasmatic PPi level dosage at visit 1
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Plasmatic PPi level, ENPI level and CT-scan of coronary arteries and lower limbs arteriesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Measurement of plasma inorganic pyrophosphate level
Measurement of plasma inorganic pyrophosphate level in Type 2 diabetes patients and comparaison with a laboratory reference value
Time frame
Blood samples are taken during first visit, in the morning, after fastingSecondary outcomes
1
Coronary and lower limb calcification score
The coronary and lower limb calcification score will be determined using a non-contrast Computed tomography scan of the coronary arteries and lower limbs
Time frame
The Computed tomography scan will be performed within two weeks after fisrt visitSponsors and contacts
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Source ClinicalTrials.gov