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Expression of GLP1 Receptor on Peripheral Blood Mononuclear Cells in Advanced Peripheral Artery Disease: Paving the Way for GLP1R Agonists Treatment in Chronic Limb Threatening Ischemia

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Trial details

Who runs it
University Hospital, Strasbourg, France
Trial code
NCT07340112
Record updated
14 January 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: Patients aged 40 years or older; Documented Peripheral Artery Disease (PAD): Patients must fall into one of the two following severity groups:; 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.

Exclusion: Current Specific Pharmacotherapy: Ongoing treatment with SGLT2 inhibitors (SGLT2i) or GLP-1 receptor agonists (GLP-1RA); Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes; Infection: Presence of sepsis or an active systemic infection; Malignancy: Active cancer or hematologic malignancies; Immunosuppression: History of organ transplantation or autoimmune diseases currently requiring immunosuppressive therapy; Known chronic inflammatory diseases; Advanced Renal Failure: End-stage renal disease requiring dialysis.

ClinicalTrials.gov NCT07340112