An observational study in Peripheral Arterial Disease (PAD), Claudication, Intermittent and Chronic Limb-Threatening Ischemia, sponsored by University Hospital, Strasbourg, France. Not yet recruiting at 1 site in France. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by University Hospital, Strasbourg, France · Observational
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:
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:
Participation ends after completion of the blood sampling, and no additional procedures beyond standard clinical care are required.
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 50 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented Peripheral Artery Disease (PAD): Patients must fall into one of the two following severity groups:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
One-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.
Time frame: Day 1 (at the time of the one-time blood sampling)
Systemic Pro-inflammatory Cytokine Profile
Concentration of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α) measured in pg/mL using ELISA
Time frame: Day 1
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).
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2028, 24 months later.
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France →