Type 2 DiabetesGENTLENCT06590415
Trancriptomics and Lipidomics of Epicardial Ectopic Fat
A study testing Subcutaneous adipose tissue biopsy and Blood sampling in people with Type 2 Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Cohort studies have shown that patients with obesity associated with metabolic abnormalities (metabolically unhealthy obesity) have an accumulation of ectopic fat deposits (EDF) linked to subcutaneous adipose tissue dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Subcutaneous adipose tissue biopsy and Blood sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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 less than or equal to 40 years and epicardial fat volume greater than 72 mL*.
- Patient beneficiary or affiliated to a social security scheme
Show all 12Show fewer
- 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
Who cannot join
- Type 1 diabetic patient
- Patient with monogenic diabetes
- Patient with diabetes secondary to pancreatic disease
- Pregnant or breast-feeding women, patients under guardianship, deprived of liberty.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assistance Publique - Hôpitaux de Marseille
Marseille, 13005
Lauren Agnelli, 0491435186, lauren.agnelli@ap-hm.fr
Benedicte Gaborit
About this study
Cohort studies have shown that patients with obesity associated with metabolic abnormalities (metabolically unhealthy obesity) have an accumulation of ectopic fat deposits (EDF) linked to subcutaneous adipose tissue dysfunction. Although it is accepted that the storage capacity of subcutaneous adipose tissue is genetically determined, the genetic factors predisposing to adipose tissue distribution abnormalities remain poorly understood.
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.
Read more
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).
- Conditions
- Type 2 Diabetes
- Being tested
- Subcutaneous adipose tissue biopsy, Blood sampling
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous adipose tissue biopsyProcedure or surgery
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 samplingOther
One 4 mL tube of blood will be collected
| Study group | Role | What they receive |
|---|---|---|
| T2D/DGE patients | Experimental | Diagnostic age of diabètes mellitus less than or equal to 40 years and epicardial fat volume greater than 72 mL. Receives: Procedure: Subcutaneous adipose tissue biopsy; Other: Blood sampling |
| Control patients | Active comparator | Age at diagnosis of diabetes greater than 40 and/or epicardial fat volume less than 72 mL. Receives: Procedure: Subcutaneous adipose tissue biopsy; Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of variants genes
Higher frequency of rare heterozygous missense variants of lipodystrophy genes, or the presence of variants more often classified as pathogenic or of unknown significance (according to the ACMG classification) in the target group compared with the control group.
A variant is considered rare if its frequency in GnomAD is \< 1%.
Measured: Day 1
Secondary outcomes (3)
Plasma and adipocyte lipidic profil determined by mass spectrometry
Identification of plasma and adipocyte lipid species whose expression is significantly altered in patients according to their phenotype and genotype (T2D/DGE versus controls)
Measured: Day 1
Integrative multiomic analysis including clinical, biological, exomic, transcriptomic and lipidomic data.
identification of a multiomic signature that would differentiate the 2 groups: Early T2D/DGE and controls.
Measured: Day 1
Gene expression profil in subcutaneous adipose tissue determined by mRNA sequencing
identification of genes whose expression is significantly altered in patients according to their phenotype and genotype (comparison of early T2D/DGE versus controls) in subcutaneous adipose tissue
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590415
- Sponsor's protocol ID
- RCAPHM24_0060
- Acronym
- GENTLE
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trancriptomics and Lipidomics of Epicardial Ectopic Fat
- ClinicalTrials.gov ID
- NCT06590415
- Acronym / sponsor ID
- GENTLE / RCAPHM24_0060
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
Cohort studies have shown that patients with obesity associated with metabolic abnormalities (metabolically unhealthy obesity) have an accumulation of ectopic fat deposits (EDF) linked to subcutaneous adipose tissue dysfunction. Although it is accepted that the storage capacity of subcutaneous adipose tissue is genetically determined, the genetic factors predisposing to adipose tissue distribution abnormalities remain poorly understood.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2D/DGE patients | Experimental | Procedure: Subcutaneous adipose tissue biopsy, Other: Blood samplingDiagnostic age of diabètes mellitus less than or equal to 40 years and epicardial fat volume greater than 72 mL. |
| Control patients | Active comparator | Procedure: Subcutaneous adipose tissue biopsy, Other: Blood samplingAge at diagnosis of diabetes greater than 40 and/or epicardial fat volume less than 72 mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 less than or equal to 40 years and epicardial fat volume greater than 72 mL*.
Key exclusion criteria (4 listed)
- Type 1 diabetic patient
- Patient with monogenic diabetes
- Patient with diabetes secondary to pancreatic disease
- Pregnant or breast-feeding women, patients under guardianship, deprived of liberty.
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 |
|---|---|---|
| Subcutaneous adipose tissue biopsyUnder local anesthesia, subcutaneous adipose tissue will be collected from 2 puncture points in the umbilical region for a total volume of 2 mL. | Procedure or surgery | Control patients, T2D/DGE patients |
| Blood samplingOne 4 mL tube of blood will be collected | Other | Control patients, T2D/DGE patients |
Primary outcome
Frequency of variants genes
Time frame: Day 1
Higher frequency of rare heterozygous missense variants of lipodystrophy genes, or the presence of variants more often classified as pathogenic or of unknown significance (according to the ACMG classification) in the target group compared with the control group. A variant is considered rare if its frequency in GnomAD is \< 1%.
3 secondary outcomes
Plasma and adipocyte lipidic profil determined by mass spectrometry
Time frame: Day 1
Integrative multiomic analysis including clinical, biological, exomic, transcriptomic and lipidomic data.
Time frame: Day 1
Gene expression profil in subcutaneous adipose tissue determined by mRNA sequencing
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous adipose tissue biopsy and Blood sampling in people with Type 2 Diabetes, run by Assistance Publique Hopitaux De Marseille 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 12 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benedicte Gaborit, Pr (0491968723, benedicte.gaborit@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of variants genes (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.