Arterial Calcification in the Diabetes

Arteriosclerosis Obliterans Clinical Trial

— DIACART  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02431234
• Other study ID #: P111105
• Status: Active, not recruiting
• Start date: February 2014
• Est. completion date: September 2018

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 169
• Est. completion date: September 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis Obliterans
• Calcinosis
• Diabetic Angiopathies
• Diabetic Vascular Diseases
• Monckeberg Medial Calcific Sclerosis
• Vascular Calcification
• Vascular Diseases

Intervention

Other:
• serum RANKL

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié Salpetrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum RANKL concentrations	Serum RANKL concentrations to predict the progression of calcification of the leg arteries in diabetic patients, (independently of other cardiovascular risk factors)	Baseline