Diabetic PatientsMETAB-CV-PWVNCT05681533
Epicardial Adipose Tissue and Arterial Stiffness in People Living With Diabetes (METAB-CV-PWV)
An observational study of Diabetic Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Patients
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2021to Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
endocrinologie site, Avicenne hospital
Bobigny, 93000
Emmanuel COSSON, Pr, emmanuel.cosson@aphp.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Patients
- Being tested
- CT scan
- Keywords
- Diabet, arterial stiffness, pericardial adipose tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanProcedure or surgery
coronary calcium score measurement by CT scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial fat volume
Epicardial fat volume will be determined using cardiac CT scan without contrast injection.
Measured: the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start31 Mar 2021
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel COSSON, Pr, Principal investigator, APHP, Hospital Avicenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681533
- Sponsor's protocol ID
- APHP220876
- Acronym
- METAB-CV-PWV
- Status last verified
- Nov 2022
- First submitted
- 7 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41094476
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissu Adipeux épicardique et rigidité artérielle Chez Les Personnes Vivant Avec un diabète
- ClinicalTrials.gov ID
- NCT05681533
- Acronym / sponsor ID
- METAB-CV-PWV / APHP220876
- Conditions
- Diabetic Patients
- Keywords
- Diabet, arterial stiffness, pericardial adipose tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scancoronary calcium score measurement by CT scan | Procedure or surgery | – |
Primary outcome
Epicardial fat volume
Time frame: the inclusion visit
Epicardial fat volume will be determined using cardiac CT scan without contrast injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 41094476Koutcha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COSSON, Pr principal investigator
APHP, Hospital Avicenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Patients, 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 4 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 12 Jan 2023. 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?
Contact Emmanuel COSSON, Pr (01 48 95 51 54, emmanuel.cosson@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial fat volume (time frame: the inclusion visit). 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 NCT05681533, which also lists 1 linked publication.
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 12 Jan 2023.