Study of the Mechanisms of the Arterial Calcification of the Members Subordinates in the Diabetes (Implication of the System RANK / RANKL / OSTEOPROTEGERINE)

Arterial Calcification in the Diabetes

Sponsors

Lead sponsor: Assistance Publique - Hôpitaux de Paris

Source Assistance Publique - Hôpitaux de Paris
Brief Summary

The blood concentration of the protein RANKL could be predictive of the calcification of the leg arteries, which is a major complication occurring during diabetes. The objective of the DIACART study is to show that blood RANKL concentration predict the progression of calcification of the leg arteries in diabetic patients, independently of other cardiovascular risk factors.

Detailed Description

Introduction: Peripheral arterial disease (PAD) is the primary major amputation risk factor in diabetes. The PAD is particularly common among diabetic patients at high cardiovascular risk (20-30% of coronary patients have PAD). The calcification of atherosclerotic plaque and media leg arteries contributes to narrowing of the arterial lumen and exposes the diabetic patient to critical limb ischemia. The receptor RANK (Receptor Activator for Nuclear Factor κ B) and its ligand RANKL form a complex which initially was described as being involved in bone metabolism by activating osteoclasts but the RANK / RANKLigand system could also be involved in the process calcification and arterial obstruction, especially in the lower limbs. Currently there is anti-RANKL antibody used in humans that could possibly slow down this process. But it is necessary to prove the involvement of this system in PAD in diabetic patients at high cardiovascular risk before proposing a therapeutic trial.

Assumptions: the concentration of RANKL could be predictive of calcification of leg arteries in diabetes Main objective: To show that serum RANKL concentrations predict the progression of calcification of the leg arteries in diabetic patients, independently of other cardiovascular risk factors.

Secondary Objectives:

- To show the link between other proteins of bone remodeling, markers of inflammation and glycation, and calcification of leg arteries.

- Measuring the rate of calcification leg arteries.

- Phenotype diabetic patients who have the highest rate of calcification. Primary Outcome: Predictive power of serum RANKL concentration at T0 on the progression of calcification of leg arteries between T0 and T24 months.

Methodology: prospective observational study. The calcium score of leg arteries will be evaluated by a scanner at T0 and 24 months.

Inclusion criteria:

- type 2 diabetes

- women over 60

- men over 50 years

- men and women with known coronary artery disease Non-inclusion criteria:

- severe renal failure

- immunodeficiency

- acute infectious or inflammatory disease

- history of bypass surgery or sub-popliteal angioplasty Number of subjects required: 188 patients will be included. Total study duration: 24 months Inclusion period: 24 months

Overall Status Unknown status
Start Date February 2014
Completion Date September 2018
Primary Completion Date February 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Serum RANKL concentrations Baseline
Enrollment 169
Condition
Intervention

Intervention type: Other

Intervention name: serum RANKL

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion criteria:

- type 2 diabetes

- women over 60

- men over 50 years

- men and women with known coronary artery disease

Non-Exclusion criteria:

- severe renal failure

- immunodeficiency

- acute infectious or inflammatory disease

- history of bypass surgery or sub-popliteal angioplasty

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Olivier Bourron, MD, PhD Principal Investigator Assistance Publique - Hôpitaux de Paris
Location
facility Groupe Hospitalier Pitié Salpetrière
Location Countries

France

Verification Date

May 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym DIACART
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov