High CholesterolEPICAC-RUNNCT07090629
The Benefits of the Measureof Epicardial Adipose Tissue During Coronary Calcium Assessment of the Refine Cardiovascular Risk Assessment at Reunion Island.
An observational study of High Cholesterol and Lipodystrophy, Familial Partial, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
The goal of this retrospective study is to see whether patients with familial partial type 2 lipodystrophy, who are at high cardiovascular risk present a higher volume of visceral epicardial adipose tissue than other patients without familial partial lipodystrophy who were assessed for their cardiovascular risk using… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Cholesterol, Lipodystrophy, Familial Partial, Diabetes
- What is being tested?
- Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoring
- How many people
- 126 participants
- Where
- 1 siteReunion
- Study dates
- 6 May 2024to 21 Mar 2025
- 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: Patients who received a check-up for hypercholesterolemia, obesity or diabetes including a CT scan to measure the coronary calcium score at the CHU de La Réunion between 2016 and 2023
Who may be able to join
- Patients who received a check-up for hypercholesterolemia, obesity or diabetes including a CT scan to measure the coronary calcium score at the CHU de La Réunion between 2016 and 2023
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this retrospective study is to see whether patients with familial partial type 2 lipodystrophy, who are at high cardiovascular risk present a higher volume of visceral epicardial adipose tissue than other patients without familial partial lipodystrophy who were assessed for their cardiovascular risk using coronary artery calcification scoring between 2016 and 2024.
Read the detailed description
Coronary artery calcification and clinical cardiovascular risk scoring are insufficient for patients with Familial Partial Lipodystrophy Part 2 (FPLD2), who often develop cardiovascular events before 40 and are insulin resistant. Epicardial adipose tissue volume could be a new, earlier marker of interest for these patients related to inflammation and atherosclerosis. The investigators retrospectively included high cardiovascular risk patients from 2016 to 2023 who had benefited from coronary artery calcification and clinical risk scoring at the University Hospital of La Réunion with Familial Partial Lipodystrophy Type 2 or controls and paired them for age, sex and body mass index. Epicardial adipose tissue volume was measured on the same tododensitometry as the CAC scoring, using a semi, automated technique that had been validated with deep learning at the Univeristy Hospital of Aix-Marseille.
- Conditions
- High Cholesterol, Lipodystrophy, Familial Partial, Diabetes
- Being tested
- Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoring
- Keywords
- coronary calcium score, epicardial adipose tissue, cardiovascular risk scoring, lipodystrophy
- Medical subject headings
- Hypercholesterolemia, Lipodystrophy, Familial Partial, Diabetes Mellitus, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoringOther
Epicardial adipose tissue measurement
| Study group | Role | What they receive |
|---|---|---|
| Familial Partial Lipodystrophy, Type 2 (FPLD) | Adult patients with a confirmed genetic diagnosis of lipodystrophy Receives: Other: Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoring | |
| Control group of patients at high cardiovascular risk (CTL) | Patients without Familial Partial Lipodystrophy Receives: Other: Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial adipose tissue volume
in mL
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start6 May 2024
- Primary completion29 Dec 2024
- Study completion21 Mar 2025
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 High CholesterolStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université, Institut National de la Santé Et de la Recherche Médicale, France, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090629
- Sponsor's protocol ID
- 2024/CHU/21
- Other IDs
- 2024/CHU/21
- Acronym
- EPICAC-RUN
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simonson M, Ancel P, Mortier R, Mariko ML, Fontaine B, Koue-Chon-Lim J, Martel J, Nobecourt E, Gaborit B. Epicardial adipose tissue measurement is an interesting biomarker for cardiovascular health in a case control study of patients with familial partial type 2 lipodystrophy. Diabetes Metab. 2026 Jan;52(1):101719. doi: 10.1016/j.diabet.2025.101719. Epub 2025 Dec 3.
PubMed 41349713
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of the Measureof Epicardial Adipose Tissue During Coronary Calcium Assessment of the Refine Cardiovascular Risk Assessment at Reunion Island.
- ClinicalTrials.gov ID
- NCT07090629
- Acronym / sponsor ID
- EPICAC-RUN / 2024/CHU/21
- Conditions
- High Cholesterol, Lipodystrophy, Familial Partial, Diabetes
- Keywords
- coronary calcium score, epicardial adipose tissue, cardiovascular risk scoring, lipodystrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Aix Marseille Université, Institut National de la Santé Et de la Recherche Médicale, France, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- 6 May 2024 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 29 Jul 2025 (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 goal of this retrospective study is to see whether patients with familial partial type 2 lipodystrophy, who are at high cardiovascular risk present a higher volume of visceral epicardial adipose tissue than other patients without familial partial lipodystrophy who were assessed for their cardiovascular risk using coronary artery calcification scoring between 2016 and 2024.
Detailed description
Coronary artery calcification and clinical cardiovascular risk scoring are insufficient for patients with Familial Partial Lipodystrophy Part 2 (FPLD2), who often develop cardiovascular events before 40 and are insulin resistant. Epicardial adipose tissue volume could be a new, earlier marker of interest for these patients related to inflammation and atherosclerosis. The investigators retrospectively included high cardiovascular risk patients from 2016 to 2023 who had benefited from coronary artery calcification and clinical risk scoring at the University Hospital of La Réunion with Familial Partial Lipodystrophy Type 2 or controls and paired them for age, sex and body mass index. Epicardial adipose tissue volume was measured on the same tododensitometry as the CAC scoring, using a semi, automated technique that had been validated with deep learning at the Univeristy Hospital of Aix-Marseille.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familial Partial Lipodystrophy, Type 2 (FPLD) | – | Other: Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoringAdult patients with a confirmed genetic diagnosis of lipodystrophy |
| Control group of patients at high cardiovascular risk (CTL) | – | Other: Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoringPatients without Familial Partial Lipodystrophy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received a check-up for hypercholesterolemia, obesity or diabetes including a CT scan to measure the coronary calcium score at the CHU de La Réunion between 2016 and 2023
Key inclusion criteria (1 listed)
- Patients who received a check-up for hypercholesterolemia, obesity or diabetes including a CT scan to measure the coronary calcium score at the CHU de La Réunion between 2016 and 2023
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoringEpicardial adipose tissue measurement | Other | Control group of patients at high cardiovascular risk (CTL), Familial Partial Lipodystrophy, Type 2 (FPLD) |
Primary outcome
Epicardial adipose tissue volume
Time frame: at inclusion
in mL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 41349713Simonson M, Ancel P, Mortier R, Mariko ML, Fontaine B, Koue-Chon-Lim J, Martel J, Nobecourt E, Gaborit B. Epicardial adipose tissue measurement is an interesting biomarker for cardiovascular health in a case control study of patients with familial partial type 2 lipodystrophy. Diabetes Metab. 2026 Jan;52(1):101719. doi: 10.1016/j.diabet.2025.101719. Epub 2025 Dec 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 High Cholesterol and Lipodystrophy, Familial Partial, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jul 2025. 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 Reunion. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Epicardial adipose tissue volume (time frame: at inclusion). 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 NCT07090629, 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 31 Jul 2025.