Arteriosclerosis Obliterans Clinical Trial
Official title:
Study of the Mechanisms of the Arterial Calcification of the Members Subordinates in the Diabetes (Implication of the System RANK / RANKL / OSTEOPROTEGERINE)
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.
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
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