DIACART: Arterial Calcification in the Diabetes

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT02431234

Collaborator

(none)

169

Enrollment

Location

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Vascular Diseases Arteriosclerosis Obliterans Monckeberg Medial Calcific Sclerosis	Other: serum RANKL

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

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

169 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Anticipated Study Completion Date :

Sep 1, 2018

Outcome Measures

Primary Outcome Measures

Serum RANKL concentrations [Baseline]
Serum RANKL concentrations to predict the progression of calcification of the leg arteries in diabetic patients, (independently of other cardiovascular risk factors)