Long-term Follow-up of Diabetic Patients From the GLUTADIAB Study (GlutaDiab2)

Assistance Publique - Hôpitaux de Paris

Status: Begins enrollment this month

Conditions: Diabetes

Treatments: Biological: blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT07347613

2025-A02804-45

Details and patient eligibility

About

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.

Full 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

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

450 participants in 2 patient groups

Group 1

Description:

Patients with uncomplicated diabetes and low cardiovascular risk

Treatment:

Biological: blood sampling

Group 2

Description:

Patients with uncomplicated diabetes and high cardiovascular risk

Treatment:

Biological: blood sampling