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

NCT07005986 | Recruiting

• 2 other identifiers: 24-AOIP-04IDRCB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Type 2 Diabetes; Type 2 Diabetes Patients

Keywords

Type 2 diabetes

Outcome Measures

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

  Blood samples are taken during first visit, in the morning, after fasting

Secondary Outcomes (1)

• Coronary and lower limb calcification score

  The Computed tomography scan will be performed within two weeks after fisrt visit

Study Arms (1)

Plasmatic PPi level, ENPI level and CT-scan of coronary arteries and lower limbs arteries

EXPERIMENTAL

Diagnostic Test: Plasmatic PPi level

Interventions

Plasmatic PPi level DIAGNOSTIC_TEST

Plasmatic PPi level dosage at visit 1

Plasmatic PPi level, ENPI level and CT-scan of coronary arteries and lower limbs arteries

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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).
• Patients with chronic kidney disease (from stage 3, i.e. GFR \< 59 ml/min/1.73 m2).
• Patient with a recent fracture (within the last 3 months).
• Patient treated with AVK or biphosphonates.
• Patient with known, treated osteoporosis.
• Patient with unsupplemented vitamin D deficiency.
• Patient with active cancer.
• Patient with an active inflammatory pathology.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Nicolas NC Chevalier, Professor

CONTACT

0492034702; causeret.m@chu-nice.fr

Marion CAUSERET

CONTACT

+33492034702; causeret.m@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 5, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): July 18, 2026
• Study Completion (Estimated): July 18, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)