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 | Not Yet Recruiting

• 1 other identifier: 9908
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Peripheral arterial disease; Chronic limb-threatening ischemia; GLP-1 receptor; Peripheral blood mononuclear cells (PBMC)

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 (at the time of the one-time blood sampling)

Secondary Outcomes (2)

• Systemic Pro-inflammatory Cytokine Profile

  Day 1

• Oxidative and Nitrosative Stress Markers in PBMCs

  Day 1

Study Arms (2)

Chronic Limb-Threatening Ischemia (CLTI)

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

Diagnostic Test: Analysis of GLP-1 receptor expression

Intermittent claudication (IC)

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

Diagnostic Test: Analysis of GLP-1 receptor expression

Interventions

Analysis of GLP-1 receptor expression DIAGNOSTIC_TEST

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

Chronic Limb-Threatening Ischemia (CLTI); Intermittent claudication (IC)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118: collaborator

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample (15 mL)

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Study Design

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

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)