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

NCT07347613 | Not Yet Recruiting

• 1 other identifier: 2025-A02804-45
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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

Diabetes

Keywords

glutamine; cardiovascular

Outcome Measures

Primary Outcomes (1)

• 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.

  inclusion

Secondary Outcomes (8)

• To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline

  inclusion

• To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline

  inclusion

• To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline

  inclusion

• To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline

  inclusion

• To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline

  inclusion

Study Arms (2)

Group 1

Patients with uncomplicated diabetes and low cardiovascular risk

Biological: blood sampling

Group 2

Patients with uncomplicated diabetes and high cardiovascular risk

Biological: blood sampling

Interventions

blood sampling BIOLOGICAL

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult Type 1 and 2 diabetic patients

You may not qualify if:

• Pregnant or breastfeeding woman
• Absence of free and informed consent
• Subject deprived of freedom, subject under a legal protective measure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Lariboisière hospital

Paris, 75010, France

Location

Diabétologie

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Louis POTIER

  Bichat Hospital

  STUDY CHAIR

Central Study Contacts

Annabelle METOIS

CONTACT

01 40 25 79 39; annabelle.metois@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)