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

NCT07347613 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2026-04-17

No results posted yet for this study

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.

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.

Conditions

Interventions

BIOLOGICAL

blood sampling

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Louis POTIER · Bichat Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2031-05-01
Completion
2031-05-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347613 on ClinicalTrials.gov