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Not yet recruiting NCT07347613

Long-term Follow-up of Diabetic Patients From the GLUTADIAB Study

Conditions: Diabetes

Sponsor: Assistance Publique - Hôpitaux de Paris

trial.available_in: БГ
Overview
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.
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
Who can participate
Inclusion Criteria: * Person previously enroled in the GLUTADIAB study in group 1 or 2 (cf appendix 1 for GLUTADIAB inclusion criteria) Exclusion Criteria: * Pregnant or breastfeeding woman * Absence of free and informed consent * Subject deprived of freedom, subject under a legal protective measure
Interventions
blood sampling
BIOLOGICAL
Locations 2
France (2)
Lariboisière hospital
Paris
Diabétologie
Paris
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.05.2031
Registry ID
NCT07347613
Source
clinicaltrials.gov
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