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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-06-30

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Chronic limb-threatening ischemia is the most severe stage of lower-limb peripheral arterial disease and remains associated with poor cardiovascular and limb prognosis. This condition is characterized by a pronounced systemic inflammatory and oxidative state, in which peripheral blood mononuclear cells play a central role.

Glucagon-like peptide-1 receptor agonists have shown anti-inflammatory and cardiovascular protective effects in other settings, but the involvement of the GLP-1 receptor in severe peripheral arterial disease has not been clearly established. This pilot study aims to characterize GLP-1 receptor expression on peripheral blood mononuclear cells according to disease severity and to evaluate its association with inflammatory, oxidative, and proteomic profiles.

This is a monocentric, cross-sectional observational study conducted at the CHU of Strasbourg. Patients hospitalized for evaluation of symptomatic lower-limb peripheral arterial disease will be classified into intermittent claudication or chronic limb-threatening ischemia groups. A single additional blood sample will be collected during routine clinical sampling. Peripheral blood mononuclear cells and plasma will be analyzed to assess GLP-1 receptor expression, inflammatory and oxidative markers, and plasma proteomic signatures. Exploratory in-vitro experiments will evaluate the ability of GLP-1 receptor agonists to reverse endothelial alterations induced by patient plasma.

The study is designed to generate mechanistic data supporting the GLP-1 receptor as a potential therapeutic target in chronic limb-threatening ischemia and to inform future interventional studies.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic Limb-Threatening Ischemia (CLTI)

A group of patients presenting with chronic limb-threatening ischemia, the most severe form of peripheral artery disease

Analysis of GLP-1 receptor expression

Intervention Type DIAGNOSTIC_TEST

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

Intermittent claudication (IC)

A group of patients presenting with intermittent claudication, a less advanced stage of of peripheral artery disease, serving as a comparator

Analysis of GLP-1 receptor expression

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Analysis of GLP-1 receptor expression

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No