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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05681533
Other study ID # APHP220876
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 31, 2021
Est. completion date March 2023

Study information

Verified date November 2022
Source Assistance Publique - Hôpitaux de Paris
Contact Emmanuel COSSON, Pr
Phone 01 48 95 51 54
Email emmanuel.cosson@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date March 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
CT scan
coronary calcium score measurement by CT scan

Locations

Country Name City State
France endocrinologie site, Avicenne hospital Bobigny

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 Epicardial fat volume Epicardial fat volume will be determined using cardiac CT scan without contrast injection. the inclusion visit
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