Epicardial Adipose Tissue and Arterial Stiffness in People Living With Diabetes (METAB-CV-PWV) (METAB-CV-PWV)

December 26, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Tissu Adipeux épicardique et rigidité artérielle Chez Les Personnes Vivant Avec un diabète

The present study is a retrospective and prospective current care cohort that will allow us to evaluate the relationship between epicardial fat volume and increased arterial stiffness in a person living with diabetes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Epicardial adipose tissue is considered as the cardiac visceral fat and is associated with increased cardiovascular risk, for example in diabetes. Thus, the mechanisms involved seem to be related to myocardial lipotoxicity; atherosclerosis in connection with inflammation and secretion of proinflammatory factors such as cytokines but also insulin resistance.

In this context, the investigators hypothesize that epicardiac adipose tissue volume will be higher in patients with increased arterial stiffness than in those without. In this study, the investigators will then try to verify the existence of a relationship between pericardial adipose tissue volume and increased arterial stiffness in people living with diabetes.

To do this, the investigators will analyze the results of measurements of pericardial fat volume, coronary calcium score, and pulse wave velocity in diabetic patients.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 1 or 2 diabetic patients who perform coronary calcium score measurement by CT scan and pulse wave velocity assessment as part of their routine care practice.

Description

Inclusion Criteria:

Patients will be eligible for participation in the study if:

  • They are informed and have not objected to participating in the research.
  • They have type 1 or 2 diabetes.
  • They perform a coronary calcium score measurement by CT scan and a pulse wave velocity assessment during their routine care practice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epicardial fat volume
Time Frame: the inclusion visit
Epicardial fat volume will be determined using cardiac CT scan without contrast injection.
the inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Emmanuel COSSON, Pr, APHP, Hospital Avicenne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP220876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Patients

Clinical Trials on CT scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe