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GlutamineGLUTADIABNCT04353869

Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications

An observational study of Glutamine and Diabetic, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glutamine, Diabetic, Cardiovascular Complications
What is being tested?
Bio collection
How many people
995 participants
Where
2 sitesFrance
Study dates
16 Nov 2020to 10 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult Type 1 and 2 diabetic patients and non-diabetic subjects with various levels of cardiovascular risk

Who may be able to join

None listed.

Who cannot join

  • Solid organ or bone marrow transplant patient
  • Pregnant or breastfeeding woman
  • Absence of free and informed consent
  • Non-affiliation to a social security regimen or CMU (universal health coverage)
  • Subject deprived of freedom, subject under a legal protective measure

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Diabétologie - Hôpital Lariboisière

    Paris, France, 75010

  • Diabetologie Bichat

    Paris, France, 75018

Other trials in France

About this study

Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans

Read the detailed description

The aim of the study is to investigate the role of glutamine metabolism in the pro-inflammatory activation of macrophages in diabetes and related cardiovascular complications.

The study focuses on 3 adult patients' population with different diabetic status and level of cardiovascular risk:

  • Patients with uncomplicated type 1 or type 2 diabetes and low cardiovascular risk
  • Patients with uncomplicated type 1 or type 2 diabetes and high cardiovascular risk
  • Patients with complicated type 1 or type 2 diabetes

Participants (n=975) will be recruited at clinical sites, in the diabetes and cardiology departments (APHP, Bichat - Claude-Bernard Hospital and APHP, Lariboisière Hospital), over a 2-year period.

The study will consist in a single visit. During a scheduled hospitalization or consultation as part of the follow-up of their diabetes or as part of the follow-up of their cardiological problems, clinical data will be collected as well as additional blood and urine samples for analyses and biobanking. There will be no other intervention specific to the study.

Being tested
Bio collection
Keywords
Diabetes, Cardiovascular complications, Glutamine metabolism
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bio collectionBiological

    venous blood sampling and collection of urine

Study groups in NCT04353869
Study groupRoleWhat they receive
Group 1Patients with uncomplicated diabetes and low cardiovascular risk 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 9 tubes: 4 x 7 mL EDTA (Éthylènediaminetétraacétique) tubes + 3 x 5 mL EDTA tubes + 2 x 4 mL no additive tubes (total: 51 mL) at a single time during the study and collection of 2 monovettes of 1.6 ml urine (total: 3.2 mL).
Receives: Biological: Bio collection
Group 2Patients with uncomplicated diabetes and high cardiovascular risk 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 9 tubes: 4 x 7 mL EDTA tubes + 3 x 5 mL EDTA tubes + 2 x 4 mL no additive tubes (total: 51 mL) at a single time during the study and collection of 2 monovettes of 1.6 ml urine (total: 3.2 mL).
Receives: Biological: Bio collection
Group 3Patients with complicated diabetes 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 9 tubes: 4 x 7 mL EDTA tubes + 3 x 5 mL EDTA tubes + 2 x 4 mL no additive tubes (total: 51 mL) at a single time during the study and collection of 2 monovettes of 1.6 ml urine (total: 3.2 mL).
Receives: Biological: Bio collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the plasma concentrations of glutamine in patients with various levels of cardiovascular (CV) risk.

    plasma concentration of glutamine in each subject.

    Measured: DAY 1

Secondary outcomes (10)

  1. Study glutamine metabolism in patients with various levels of CV risk

    plasma concentration of glutamate in each treatment group

    Measured: DAY 1

  2. Study glutamine metabolism in patients with various levels of CV risk

    plasma concentration of a-ketoglutarate, fumarate, and succinate in each treatment group

    Measured: DAY1

  3. Study glutamine metabolism in patients with various levels of CV risk

    monocyte cytoplasmic concentration of a-ketoglutarate, fumarate and succinate in each treatment group

    Measured: DAY 1

  4. study the inflammatory status in patients with various levels of CV risk

    plasma concentration of VEGF (Vascular endothelial growth factor) in each treatment group

    Measured: DAY 1

  5. study the inflammatory status in patients with various levels of CV risk

    plasma concentration of the proinflammatory cytokines IL-1, IL-6, IL-8 (interleukin) and TNF-a (Tumor Necrosis Factor alpha)

    Measured: DAY 1

  6. study the inflammatory status in patients with various levels of CV risk

    blood concentration of circulating PBMCs (peripheral blood mononuclear cell)

    Measured: DAY 1

  7. study the monocyte activation status in patients with various levels of CV risk

    frequency of monocyte subsets (CD14++CD16+, CD14++CD16++, CD14+CD16++)

    Measured: DAY 1

  8. characterize the transcriptomic program through modification gene expression and epigenetic changes related to KDM6B (Lysine Demethylase 6B) and TET2 (Ten-eleven-translocation 2) activity in blood monocytes from patients with various levels of CV risk

    Number of transcript for each gene

    Measured: DAY 1

  9. characterize the transcriptomic program through modification gene expression and epigenetic changes related to KDM6B and TET2 activity in blood monocytes from patients with various levels of CV risk

    Number of methylated gene loci and their proportion of methylation

    Measured: DAY 1

  10. characterize the transcriptomic program through modification gene expression and epigenetic changes related to KDM6B and TET2 activity in blood monocytes from patients with various levels of CV risk

    Frequency and level of histone H3K27me (Methylation of lysine 27 on histone H3) methylation

    Measured: DAY 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start16 Nov 2020
  3. Primary completion10 Jan 2024
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
995 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353869
Sponsor's protocol ID
GLUTADIAB
Acronym
GLUTADIAB
Status last verified
Mar 2024
First submitted
16 Apr 2020
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Julla JB, Girard D, Diedisheim M, Saulnier PJ, Tran Vuong B, Bleriot C, Carcarino E, De Keizer J, Orliaguet L, Nemazanyy I, Potier C, Khider K, Tonui DC, Ejlalmanesh T, Ballaire R, Mambu Mambueni H, Germain S, Gaborit B, Vidal-Trecan T, Riveline JP, Garchon HJ, Fenaille F, Lemoine S, Carlier A, Castelli F, Potier L, Masson D, Roussel R, Vandiedonck C, Hadjadj S, Alzaid F, Gautier JF, Venteclef N. Blood Monocyte Phenotype Is A Marker of Cardiovascular Risk in Type 2 Diabetes. Circ Res. 2024 Jan 19;134(2):189-202. doi: 10.1161/CIRCRESAHA.123.322757. Epub 2023 Dec 28.

    PubMed 38152893

Questions about this trial

What is this clinical trial studying?

An observational study of Glutamine and Diabetic, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the plasma concentrations of glutamine in patients with various levels of cardiovascular (CV) risk. (time frame: DAY 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353869, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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