The goal of this observational study is to learn whether activation of the GLP-1 receptor could represent a therapeutic target by characterizing its expression and associated inflammatory mechanisms in patients with peripheral artery disease, according to disease severity, in adults with symptomatic lower-limb peripheral arterial disease.
The main questions it aims to answer are:
* Is the level of GLP-1 receptor (GLP1R) expression on peripheral blood mononuclear cells (PBMC) different between patients with intermittent claudication (ischemia of effort) and those with chronic limb-threatening ischemia? * Is GLP1R expression associated with inflammatory and oxidative profiles of PBMC? * Can GLP-1 receptor agonists reverse inflammatory and oxidative alterations induced by plasma from patients with peripheral artery disease in endothelial cell cultures? * Are there specific plasma proteomic signatures associated with GLP1R overexpression?
Researchers will compare patients with intermittent claudication to patients with chronic limb-threatening ischemia to see if disease severity is associated with differences in GLP1R expression, PBMC inflammatory/oxidative phenotype, and plasma proteomic profiles.
Participants will:
* Provide an additional blood sample (15 mL) collected during a routine, clinically indicated blood draw * Have PBMC isolated for measurement of GLP1R expression and assessment of inflammatory and oxidative markers * Have plasma analyzed for proteomic profiling and used in in-vitro endothelial cell experiments
Participation ends after completion of the blood sampling, and no additional procedures beyond standard clinical care are required.
Patients aged 40 years or older
Intermittent Claudication (IC) Group: Defined by a maximum walking distance limited by intermittent claudication, associated with an Ankle-Brachial Index (ABI) < 0.9 at rest.
Chronic Limb-Threatening Ischemia (CLTI) Group: Defined by ischemic rest pain and/or tissue loss (ulcers or gangrene) persisting for at least 15 days, associated with a toe pressure or a transcutaneous oxygen tension (tcPO2) < 30 mmHg, according to the 2024 ESC guidelines.
Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes
Current Specific Pharmacotherapy: Ongoing treatment with SGLT2 inhibitors (SGLT2i) or GLP-1 receptor agonists (GLP-1RA).
Infection: Presence of sepsis or an active systemic infection.
Malignancy: Active cancer or hematologic malignancies.
Study participants will be recruited from the patient population managed at the Strasbourg University Hospital (CHU de Strasbourg), France. The cohort consists of individuals referred to the vascular surgery and vascular medicine departments for specialized tertiary care. Participants are identified and enrolled during their scheduled medical or surgical hospitalizations, including both outpatient day-hospital units and conventional inpatient wards. The population represents a real-world clinical sample of symptomatic patients undergoing standardized diagnostic or therapeutic evaluations for peripheral arterial conditions.
Case-control
Cross-sectional
Analysis of GLP-1 receptor expression
Diagnostic testOne-time 15mL blood sampling for GLP-1R expression analysis on PBMCs via RT-qPCR and Western blot
Level of GLP-1 Receptor (GLP-1R) Gene Expression in PBMCs
Quantification of GLP-1R mRNA expression levels in Peripheral Blood Mononuclear Cells (PBMCs) using RT-qPCR. This measure aims to compare the level of receptor expression between patients with Intermittent Claudication and those with Chronic Limb-Threatening Ischemia.
Systemic Pro-inflammatory Cytokine Profile
Concentration of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α) measured in pg/mL using ELISA
Oxidative and Nitrosative Stress Markers in PBMCs
Measurement of Nitric Oxide (NO) and Reactive Oxygen Species (ROS) levels in PBMCs using fluorescent probes and flow cytometry (expressed as Mean Fluorescence Intensity).
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University Hospital, Strasbourg, France
Lead sponsor
Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118
Collaborator
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