Trancriptomics and Lipidomics of Epicardial Ectopic Fat
NCT ID: NCT06590415
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
84 participants
INTERVENTIONAL
2024-10-01
2027-04-01
Brief Summary
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The Angiosafe T2D cohort consists of 7200 highly phenotyped type 2 diabetes (T2D) patients. In 297 patients from this cohort (ancillary study), investigators assessed epicardial fat volume (EFV) using an artificial intelligence algorithm. In 42 of these patients, designated as early T2DM/DGE, an accumulation of epicardial fat and diabetes occurring before the age of 40 were observed, clinically approaching the clinical presentation of genetic lipodystrophy, although subcutaneous adipose tissue persisted in their case.
This study will focus on a case-control study nested within the pre-existing cohort of T2D patients (Angiosafe T2D), and more specifically within this cohort on a subgroup of 42 patients with early-onset diabetes and an abnormal distribution of adipose tissue caracterized by ectopic fat accumulation. In order to understand the severe metabolic phenotype observed in this group of 42 patients, investigators propose to perform a multiomic analysis combining clinico-biological, exomic, transcriptomic and lipidomic data.
This study will compare the rate of patients with at least one rare (\<1% general population) potentially pathogenic genetic variant in a coding region of the genetic lipodystrophy genes by whole exome sequencing in 42 early-onset T2DM and a high epicardial fat volume patients versus 42 patients without early-onset T2DM and/or high epicardial fat volume (control group).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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T2D/DGE patients
Diagnostic age of diabètes mellitus less than or equal to 40 years and epicardial fat volume greater than 72 mL.
Subcutaneous adipose tissue biopsy
Under local anesthesia, subcutaneous adipose tissue will be collected from 2 puncture points in the umbilical region for a total volume of 2 mL.
Blood sampling
One 4 mL tube of blood will be collected
Control patients
Age at diagnosis of diabetes greater than 40 and/or epicardial fat volume less than 72 mL.
Subcutaneous adipose tissue biopsy
Under local anesthesia, subcutaneous adipose tissue will be collected from 2 puncture points in the umbilical region for a total volume of 2 mL.
Blood sampling
One 4 mL tube of blood will be collected
Interventions
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Subcutaneous adipose tissue biopsy
Under local anesthesia, subcutaneous adipose tissue will be collected from 2 puncture points in the umbilical region for a total volume of 2 mL.
Blood sampling
One 4 mL tube of blood will be collected
Eligibility Criteria
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Inclusion Criteria
* Patient who has signed the GENTLE informed consent form.
* Patient not objecting to re-use of data and samples collected in the Angiosafe T2D study
* Patient with type 2 diabetes according to ADA recommendations
* Age at diagnosis of diabetes less than or equal to 40 years and epicardial fat volume greater than 72 mL\*.
* Patient beneficiary or affiliated to a social security scheme
* Adult patient of legal age included in the Angiosafe T2D multicenter study, having consented to the use of the data collected for research purposes.
* Patient who has signed the GENTLE informed consent form.
* Patient not objecting to re-use of data and samples collected in the Angiosafe T2D study
* Patient with type 2 diabetes according to ADA recommendations
* Age at diagnosis of diabetes greater than 40 and/or epicardial fat volume less than 72 mL
* Patient beneficiary or affiliated to a social security scheme
Exclusion Criteria
* Patient with monogenic diabetes
* Patient with diabetes secondary to pancreatic disease
* Pregnant or breast-feeding women, patients under guardianship, deprived of liberty.
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Locations
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Assistance Publique - Hôpitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Benedicte Gaborit
Role: backup
Other Identifiers
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RCAPHM24_0060
Identifier Type: -
Identifier Source: org_study_id
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