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| Name | Class |
|---|---|
| National Research Agency, France | OTHER |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients 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). |
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| Group 2 | Patients 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). |
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| Group 3 | Patients 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio collection | Biological | venous blood sampling and collection of urine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the plasma concentrations of glutamine in patients with various levels of cardiovascular (CV) risk. | plasma concentration of glutamine in each subject. | DAY 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Study glutamine metabolism in patients with various levels of CV risk | plasma concentration of glutamate in each treatment group | DAY 1 |
| Study glutamine metabolism in patients with various levels of CV risk |
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Inclusion criteria General inclusion criteria applying to the five populations are the following:
Inclusion criteria according to study group are listed below.
Group 1: Patients with uncomplicated diabetes and low cardiovascular risk, additional inclusion criteria are:
Group 2: Patients with uncomplicated diabetes and high cardiovascular risk, additional inclusion criteria are:
Group 3: Patients with complicated diabetes, additional inclusion criteria are:
Exclusion Criteria:
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Adult Type 1 and 2 diabetic patients and non-diabetic subjects with various levels of cardiovascular risk
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabétologie - Hôpital Lariboisière | Paris | France | 75010 | France | ||
| Diabetologie Bichat |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38152893 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Venous blood, Urine
plasma concentration of a-ketoglutarate, fumarate, and succinate in each treatment group
| DAY1 |
| Study glutamine metabolism in patients with various levels of CV risk | monocyte cytoplasmic concentration of a-ketoglutarate, fumarate and succinate in each treatment group | DAY 1 |
| study the inflammatory status in patients with various levels of CV risk | plasma concentration of VEGF (Vascular endothelial growth factor) in each treatment group | DAY 1 |
| 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) | DAY 1 |
| study the inflammatory status in patients with various levels of CV risk | blood concentration of circulating PBMCs (peripheral blood mononuclear cell) | DAY 1 |
| study the monocyte activation status in patients with various levels of CV risk | frequency of monocyte subsets (CD14++CD16+, CD14++CD16++, CD14+CD16++) | DAY 1 |
| 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 | DAY 1 |
| 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 | DAY 1 |
| 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 | DAY 1 |
| Paris |
| France |
| 75018 |
| France |