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Diabetic Vascular DiseasesDIACARTNCT02431234

Arterial Calcification in the Diabetes

An observational study of Diabetic Vascular Diseases and Arteriosclerosis Obliterans, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
serum RANKL
How many people
169 participants
Where
1 siteFrance
Study dates
Feb 2014to Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Men and women with type 2 diabetes and known coronary artery disease

Who may be able to join

  • type 2 diabetes
  • women over 60
  • men over 50 years
  • men and women with known coronary artery disease
  • Non-Exclusion criteria:
  • severe renal failure
Show all 9Show fewer
  • immunodeficiency
  • acute infectious or inflammatory disease
  • history of bypass surgery or sub-popliteal angioplasty

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Pitié Salpetrière

    Paris, 75013

Other trials in France

About this study

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.

Read the 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
Being tested
serum RANKL
Keywords
Type 2 diabetes, Arterial calcification, Mediacalcosis, Calcium score
Medical subject headings
Diabetic Angiopathies, Arteriosclerosis Obliterans, Monckeberg Medial Calcific Sclerosis, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serum RANKLOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionFeb 2016
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
169 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02431234
Sponsor's protocol ID
P111105
Acronym
DIACART
Status last verified
May 2018
First submitted
27 Apr 2015
Last updated
4 Jun 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40269920

  • 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.

    PubMed 39984928

  • 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.

    PubMed 38351039

  • 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.

    PubMed 33377125

  • 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.

    PubMed 32948184

  • 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.

    PubMed 31168327

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Vascular Diseases and Arteriosclerosis Obliterans, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum RANKL concentrations (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02431234, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.

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