DiabetesGlutaDiab2NCT07347613
Long-term Follow-up of Diabetic Patients From the GLUTADIAB Study
An observational study of Diabetes, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Diabetes and related complications, particularly cardiovascular disease, are associated to exacerbated inflammation, which is characterized by an activation into a pro-inflammatory status of myeloid cells including blood monocytes and tissue macrophages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- blood sampling
- How many people
- 450 participants
- Where
- 2 sitesFrance
- Study dates
- 1 May 2026to 1 May 2031
- Phase
- Observational
- 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
Study population: Adult Type 1 and 2 diabetic patients
Who may be able to join
- Person previously enroled in the GLUTADIAB study in group 1 or 2 (cf appendix 1 for GLUTADIAB inclusion criteria)
Who cannot join
- Pregnant or breastfeeding woman
- Absence of free and informed consent
- Subject deprived of freedom, subject under a legal protective measure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Lariboisière hospital
Paris, 75010
Jean-François GAUTIER, 01 49 95 90 20, jean-francois.gautier@aphp.fr
Diabétologie
Paris, 75018
Louis POTIER, 0140258803, louis.potier@aphp.fr
About this study
Diabetes and related complications, particularly cardiovascular disease, are associated to exacerbated inflammation, which is characterized by an activation into a pro-inflammatory status of myeloid cells including blood monocytes and tissue macrophages.
It is known that monocytes and macrophages sense, integrate and respond to their microenvironment and continually monitor the availability of nutrients in order to adapt their activity and metabolism accordingly. However, the molecular mechanisms driving their activation and switch to a pro-inflammatory phenotype in diabetes are not fully elucidated.
Read more
The Tricarboxylic Acid cycle is a nexus for multiple nutrient inputs and the generation of Tricarboxylic Acid cycle metabolites is nowadays thought to orient macrophage polarization. Reduced glutamine concentrations have been reported in patients with type 2 diabetes compared to healthy individuals. Ex vivo studies (mainly performed in rodent models) have shown that glutamine catabolism (glutaminolysis) is involved in the activation of macrophages by generating Tricarboxylic Acid cycle intermediates that promote the pro-inflammatory polarization of macrophages. Yet, the link - glutamine catabolism, monocytes polarization and diabetes-related cardiovascular complications - remains unclear.
The first phase of this project (GlutaDiab) aimed to clarify this association by quantifying glutamine metabolism in serum and monocytes activation of type 1 and type 2 diabetic patients and investigating the possible correlation with the risk of cardiovascular complications in a transversal cohort.
The GlutaDiab2 is the second phase of this project and aims to further investigate the association between glutamine metabolism and cardiovascular risk by collecting follow-up data on cardiovascular events. This longitudinal data will also address the directionality of the association between glutamine metabolism, monocytes activation and cardiovascular risk.
Read the detailed description
During a scheduled hospitalization or consultation as part of the follow-up of their diabetes, additions of biological samples, which include:
A unique venous blood sampling of 10 tubes (total: 53,5 mL) at a single time during the study
- Conditions
- Diabetes
- Being tested
- blood sampling
- Keywords
- glutamine, cardiovascular
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
A unique venous blood sampling of 10 tubes: 4 x 7 mL EDTA tubes + 3 x 5 mL EDTA tubes + 2 x 4 mL no additive tubes + 1x 2,5 mL Paxgene tube (total: 53,5 mL) at a single time during the study
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with uncomplicated diabetes and low cardiovascular risk Receives: Biological: blood sampling | |
| Group 2 | Patients with uncomplicated diabetes and high cardiovascular risk Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to compare the plasma concentrations of glutamine in patients at the first visit (baseline) and the risk of cardiovascular events occurring until the GlutaDiab2 visit
The primary endpoint is the association between plasma concentration of glutamine in each subject and cardiovascular events occurring during follow-up.
Measured: inclusion
Secondary outcomes (8)
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
For the analysis of study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline:
First occurrence of a cardiovascular events according to the plasma concentration of glutamate in each treatment group
Measured: inclusion
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
For the analysis of study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline:
First occurrence of a cardiovascular events according to the plasma concentration of a-ketoglutarate, fumarate, and succinate in each treatment group
Measured: inclusion
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
For the analysis of study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline:
First occurrence of a cardiovascular events according to the monocyte cytoplasmic concentration of a-ketoglutarate, fumarate and succinate in each treatment group
Measured: inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
For the analysis of the cardiovascular events during follow-up according to the inflammatory status in patients at baseline:
First occurrence of a cardiovascular events according to the plasma concentration of VEGF (vascular endothelial growth factor) in each treatment group
Measured: inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
For the analysis of the cardiovascular events during follow-up according to the inflammatory status in patients at baseline:
First occurrence of a cardiovascular events according to the plasma concentration of the proinflammatory cytokines IL-1 béta, IL-6, IL-8 and TNF-a
Measured: inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
For the analysis of the cardiovascular events during follow-up according to the inflammatory status in patients at baseline:
First occurrence of a cardiovascular events according to the blood concentration of circulating PBMCs
Measured: inclusion
To study cardiovascular events during follow-up according to the monocyte activation status in patients at baseline
First occurrence of a cardiovascular events according to the frequency of monocyte subsets
Measured: inclusion
To study glutamine metabolism variations between baseline and follow-up visit according to variation in cardiovascular risk
To study glutamine metabolism variations between baseline and follow-up visit according to variation in cardiovascular risk In participants without cardiovascular events occurring during follow-up, cardiovascular risk will be assessed through clinical and biological data and coronary artery calcium score
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis POTIER, Study chair, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347613
- Sponsor's protocol ID
- 2025-A02804-45
- Acronym
- GlutaDiab2
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Diabetic Patients From the GLUTADIAB Study
- ClinicalTrials.gov ID
- NCT07347613
- Acronym / sponsor ID
- GlutaDiab2 / 2025-A02804-45
- Conditions
- Diabetes
- Keywords
- glutamine, cardiovascular
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 16 Jan 2026 (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.
Diabetes and related complications, particularly cardiovascular disease, are associated to exacerbated inflammation, which is characterized by an activation into a pro-inflammatory status of myeloid cells including blood monocytes and tissue macrophages.
It is known that monocytes and macrophages sense, integrate and respond to their microenvironment and continually monitor the availability of nutrients in order to adapt their activity and metabolism accordingly. However, the molecular mechanisms driving their activation and switch to a pro-inflammatory phenotype in diabetes are not fully elucidated.
The Tricarboxylic Acid cycle is a nexus for multiple nutrient inputs and the generation of Tricarboxylic Acid cycle metabolites is nowadays thought to orient macrophage polarization. Reduced glutamine concentrations have been reported in patients with type 2 diabetes compared to healthy individuals. Ex vivo studies (mainly performed in rodent models) have shown that glutamine catabolism (glutaminolysis) is involved in the activation of macrophages by generating Tricarboxylic Acid cycle intermediates that promote the pro-inflammatory polarization of macrophages. Yet, the link - glutamine catabolism, monocytes polarization and diabetes-related cardiovascular complications - remains unclear.
The first phase of this project (GlutaDiab) aimed to clarify this association by quantifying glutamine metabolism in serum and monocytes activation of type 1 and type 2 diabetic patients and investigating the possible correlation with the risk of cardiovascular complications in a transversal cohort.
The GlutaDiab2 is the second phase of this project and aims to further investigate the association between glutamine metabolism and cardiovascular risk by collecting follow-up data on cardiovascular events. This longitudinal data will also address the directionality of the association between glutamine metabolism, monocytes activation and cardiovascular risk.
Detailed description
During a scheduled hospitalization or consultation as part of the follow-up of their diabetes, additions of biological samples, which include:
A unique venous blood sampling of 10 tubes (total: 53,5 mL) at a single time during the study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: blood samplingPatients with uncomplicated diabetes and low cardiovascular risk |
| Group 2 | – | Biological: blood samplingPatients with uncomplicated diabetes and high cardiovascular risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Type 1 and 2 diabetic patients
Key inclusion criteria (1 listed)
- Person previously enroled in the GLUTADIAB study in group 1 or 2 (cf appendix 1 for GLUTADIAB inclusion criteria)
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding woman
- Absence of free and informed consent
- Subject deprived of freedom, subject under a legal protective measure
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 |
|---|---|---|
| blood samplingA unique venous blood sampling of 10 tubes: 4 x 7 mL EDTA tubes + 3 x 5 mL EDTA tubes + 2 x 4 mL no additive tubes + 1x 2,5 mL Paxgene tube (total: 53,5 mL) at a single time during the study | Biological | Group 1, Group 2 |
Primary outcome
The main objective of the study is to compare the plasma concentrations of glutamine in patients at the first visit (baseline) and the risk of cardiovascular events occurring until the GlutaDiab2 visit
Time frame: inclusion
The primary endpoint is the association between plasma concentration of glutamine in each subject and cardiovascular events occurring during follow-up.
8 secondary outcomes
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
Time frame: inclusion
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
Time frame: inclusion
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
Time frame: inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
Time frame: inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
Time frame: inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
Time frame: inclusion
To study cardiovascular events during follow-up according to the monocyte activation status in patients at baseline
Time frame: inclusion
To study glutamine metabolism variations between baseline and follow-up visit according to variation in cardiovascular risk
Time frame: inclusion
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 17 Apr 2026.
- 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.
Louis POTIER study chair
Bichat Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 1 inclusion and 3 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Annabelle METOIS (01 40 25 79 39, annabelle.metois@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective of the study is to compare the plasma concentrations of glutamine in patients at the first visit (baseline) and the risk of cardiovascular events occurring until the GlutaDiab2 visit (time frame: inclusion). 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 17 Apr 2026.