Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications

NCT04353869 | Completed

• 1 other identifier: GLUTADIAB
• Study Type: observational
• Target: 995
• Locations: 1 country
• Sites: 2

Brief 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. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans

Conditions

Glutamine; Diabetic; Cardiovascular Complications

Keywords

Diabetes; Cardiovascular complications; Glutamine metabolism

Outcome Measures

Primary Outcomes (1)

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

  plasma concentration of glutamine in each subject.

  DAY 1

Secondary Outcomes (10)

• Study glutamine metabolism in patients with various levels of CV risk

  DAY 1

• Study glutamine metabolism in patients with various levels of CV risk

  DAY1

• Study glutamine metabolism in patients with various levels of CV risk

  DAY 1

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

  DAY 1

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

  DAY 1

Study Arms (3)

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).

Biological: Bio collection

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).

Biological: Bio collection

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).

Biological: Bio collection

Interventions

Bio collection BIOLOGICAL

venous blood sampling and collection of urine

Group 1; Group 2; Group 3

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 and non-diabetic subjects with various levels of cardiovascular risk

You may qualify if:

• Age above 18 years
• BMI between 25 and 40 kg/m²
• or more years of diabetes
• % \< HbA1c \< 10%
• no history of cardiovascular event, diabetic microvascular complications (kidney function normal and albuminuria/creatininuria \< 30 mg/g)
• Coronary artery calcium score \< 100 (assessment \< 12 months)
• or more years of diabetes
• % \< HbA1c \< 10%
• no history of cardiovascular eventand diabetic nephropathy no more than stage 2 (i.e. GFR ≥ 60 ml/min by MDRD or CKD-EPI formula and albuminuria/creatininuria ≤ 30 mg/g)
• Coronary artery calcium score \> 400 (assessment \< 12 months)
• or more years of diabetes
• % \< HbA1c \< 10%
• A history of cardiovascular event (myocardial infarction, stroke, peripheral vascular disease, or angioplasty) at least 3 months ago

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• National Research Agency, France: collaborator

Study Sites (2)

Diabétologie - Hôpital Lariboisière

Paris, France, 75010, France

Location

Diabetologie Bichat

Paris, France, 75018, France

Location

Related Publications (1)

• 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.

  PMID: 38152893 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood, Urine

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: November 16, 2020
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: March 5, 2025

Record last verified: 2024-03

Locations

FR (2)