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

April 14, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult Type 1 and 2 diabetic patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients with uncomplicated diabetes and low cardiovascular risk
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
Group 2
Patients with uncomplicated diabetes and high cardiovascular risk
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
Time Frame: inclusion

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
inclusion
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
Time Frame: inclusion

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
inclusion
To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline
Time Frame: inclusion

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
inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
Time Frame: inclusion

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
inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
Time Frame: inclusion

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
inclusion
To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline
Time Frame: inclusion

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
inclusion
To study cardiovascular events during follow-up according to the monocyte activation status in patients at baseline
Time Frame: inclusion
First occurrence of a cardiovascular events according to the frequency of monocyte subsets
inclusion
To study glutamine metabolism variations between baseline and follow-up visit according to variation in cardiovascular risk
Time Frame: inclusion
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
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: Louis POTIER, Bichat hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A02804-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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