NCT05681533

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 12, 2023

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

December 7, 2022

Last Update Submit

December 26, 2022

Conditions

Diabetic Patients

Keywords

Diabetarterial stiffnesspericardial adipose tissue

Outcome Measures

Primary Outcomes (1)

  • Epicardial fat volume

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

    the inclusion visit

Interventions

CT scanPROCEDURE

coronary calcium score measurement by CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

endocrinologie site, Avicenne hospital

Bobigny, 93000, France

RECRUITING

Related Publications (1)

  • Koutcha ON, Tatulashvili S, Sritharan N, Boutouyrie P, Rezgani I, Boubaya M, Mariko ML, Allard L, Sal M, Bloch-Queyrat C, Zerguine M, Brillet PY, Fekih ZE, Bruno RM, Bihan H, Cosson E. Epicardial adipose tissue volume and arterial stiffness in people living with diabetes: the METAB-CV-PWV study. Cardiovasc Diabetol. 2025 Oct 15;24(1):400. doi: 10.1186/s12933-025-02933-z.

    PMID: 41094476DERIVED

Study Officials

  • Emmanuel COSSON, Pr

    APHP, Hospital Avicenne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel COSSON, Pr

CONTACT

01 48 95 51 54emmanuel.cosson@aphp.fr

Omar NOUHOU KOUTCHA, Dr

CONTACT

07 64 18 07 14omarnouhou1@gmail.com

Study Design

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

Study Record Dates

First Submitted

December 7, 2022

First Posted

January 12, 2023

Study Start

March 31, 2021

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

January 12, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)