Arterial Calcification in the Diabetes

NCT02431234 | Unknown

• 1 other identifier: P111105
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Vascular Diseases; Arteriosclerosis Obliterans; Monckeberg Medial Calcific Sclerosis

Keywords

Type 2 diabetes; Arterial calcification; Mediacalcosis; Calcium score

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

serum RANKL OTHER

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women with type 2 diabetes and known coronary artery disease

You may qualify if:

• type 2 diabetes
• women over 60
• men over 50 years
• men and women with known coronary artery disease

You may not qualify if:

• severe renal failure
• immunodeficiency
• acute infectious or inflammatory disease
• history of bypass surgery or sub-popliteal angioplasty

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié Salpetrière

Paris, 75013, France

Location

Related Publications (6)

• Denimal D, Ponnaiah M, Phan F, Jeannin AC, Redheuil A, Salem JE, Boussouar S, Paulstephenraj P, Laroche S, Amouyal C, Hartemann A, Foufelle F, Bourron O. Metabolic dysfunction-associated steatotic liver disease (MASLD) biomarkers and progression of lower limb arterial calcification in patients with type 2 diabetes: a prospective cohort study. Cardiovasc Diabetol. 2025 Apr 23;24(1):176. doi: 10.1186/s12933-025-02705-9.

  PMID: 40269920 DERIVED

• Le Goff W, Bourron O, Materne C, Galier S, Phan F, Tan-Chen S, Guillas I, Hartemann A, Salem JE, Redheuil A, Foufelle F, Le Stunff H, Hajduch E, Guerin M. Inverse relationship between circulating sphingosine-1-phosphate and precursor species and coronary artery calcification score in type 2 diabetes. Cardiovasc Diabetol. 2025 Feb 21;24(1):85. doi: 10.1186/s12933-025-02624-9.

  PMID: 39984928 DERIVED

• Denimal D, Ponnaiah M, Jeannin AC, Phan F, Hartemann A, Boussouar S, Charpentier E, Redheuil A, Foufelle F, Bourron O. Non-alcoholic fatty liver disease biomarkers estimate cardiovascular risk based on coronary artery calcium score in type 2 diabetes: a cross-sectional study with two independent cohorts. Cardiovasc Diabetol. 2024 Feb 13;23(1):69. doi: 10.1186/s12933-024-02161-x.

  PMID: 38351039 DERIVED

• Carlier A, Phan F, Szpigel A, Hajduch E, Salem JE, Gautheron J, Le Goff W, Guerin M, Lachkar F, Ratziu V, Hartemann A, Ferre P, Foufelle F, Bourron O. Dihydroceramides in Triglyceride-Enriched VLDL Are Associated with Nonalcoholic Fatty Liver Disease Severity in Type 2 Diabetes. Cell Rep Med. 2020 Dec 22;1(9):100154. doi: 10.1016/j.xcrm.2020.100154. eCollection 2020 Dec 22.

  PMID: 33377125 DERIVED

• Bourron O, Phan F, Diallo MH, Hajage D, Aubert CE, Carlier A, Salem JE, Funck-Brentano C, Kemel S, Cluzel P, Redheuil A, Davaine JM, Massy Z, Mentaverri R, Bonnefont-Rousselot D, Gillery P, Jaisson S, Vermeer C, Lacorte JM, Bouziri N, Laroche S, Amouyal C, Hartemann A. Circulating Receptor Activator of Nuclear Factor kB Ligand and triglycerides are associated with progression of lower limb arterial calcification in type 2 diabetes: a prospective, observational cohort study. Cardiovasc Diabetol. 2020 Sep 18;19(1):140. doi: 10.1186/s12933-020-01122-4.

  PMID: 32948184 DERIVED

• Aubert CE, Liabeuf S, Amouyal C, Kemel S, Lajat-Kiss F, Lacorte JM, Halbron M, Carlier A, Salem JE, Funck-Brentano C, Perisic Matic L, Witasp A, Stenvinkel P, Phan F, Massy ZA, Hartemann A, Bourron O. Serum concentration and vascular expression of adiponectin are differentially associated with the diabetic calcifying peripheral arteriopathy. Diabetol Metab Syndr. 2019 Apr 29;11:32. doi: 10.1186/s13098-019-0429-7. eCollection 2019.

  PMID: 31168327 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Diabetic Angiopathies; Arteriosclerosis Obliterans; Monckeberg Medial Calcific Sclerosis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Calcification; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders

Study Officials

• Olivier Bourron, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-05

Locations

FR (1)