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Starting soon Observational

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

NCT07340112 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-06
Last updated
2026-01-14

Condition(s) studied

Peripheral Arterial Disease (PAD)Claudication, IntermittentChronic Limb-Threatening Ischemia

Investigational drug(s) / intervention(s)

Analysis of GLP-1 receptor expression

Analysis of GLP-1 receptor expression: One-time 15mL blood sampling for GLP-1R expression analysis on PBMCs via RT-qPCR and Western blot

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 40 years or older * Documented Peripheral Artery Disease (PAD): Patients must fall into one of the two following severity groups: 1. 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. 2. 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 Criteria: * 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. * 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.

Primary outcome measure(s)

  • Level of GLP-1 Receptor (GLP-1R) Gene Expression in PBMCs — Day 1 (at the time of the one-time blood sampling)
    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.

Trial sites (1)

FacilityCityRegionStatus
Hôpitaux Universitaires de Strasbourg Strasbourg France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07340112 on ClinicalTrials.gov ↗ ← All trials in France