Peripheral Arterial Disease (PAD)EXCEL-CLTINCT07340112
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
An observational study of Peripheral Arterial Disease (PAD) and Claudication, Intermittent, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease (PAD), Claudication, Intermittent, Chronic Limb-Threatening Ischemia
- What is being tested?
- Analysis of GLP-1 receptor expression
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Elena-Mihaela CORDEANU, MCU-PH, +33(0)369551520 ext. +33, elena-mihaela.cordeanu@chru-strasbourg.fr
Elena-Mihaela CORDEANU, MCU-PH
About this study
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:
Read more
- 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.
Read the detailed description
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
- Peripheral Arterial Disease (PAD), Claudication, Intermittent, Chronic Limb-Threatening Ischemia
- Being tested
- Analysis of GLP-1 receptor expression
- Keywords
- Peripheral arterial disease, Chronic limb-threatening ischemia, GLP-1 receptor, Peripheral blood mononuclear cells (PBMC)
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of GLP-1 receptor expressionDiagnostic test
One-time 15mL blood sampling for GLP-1R expression analysis on PBMCs via RT-qPCR and Western blot
| Study group | Role | What they receive |
|---|---|---|
| Chronic Limb-Threatening Ischemia (CLTI) | A group of patients presenting with chronic limb-threatening ischemia, the most severe form of peripheral artery disease Receives: 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 Receives: Diagnostic Test: Analysis of GLP-1 receptor expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (at the time of the one-time blood sampling)
Secondary outcomes (2)
Systemic Pro-inflammatory Cytokine Profile
Concentration of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α) measured in pg/mL using ELISA
Measured: 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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease (PAD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340112
- Sponsor's protocol ID
- 9908
- Acronym
- EXCEL-CLTI
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07340112
- Acronym / sponsor ID
- EXCEL-CLTI / 9908
- 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)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Limb-Threatening Ischemia (CLTI) | – | Diagnostic Test: Analysis of GLP-1 receptor expressionA group of patients presenting with chronic limb-threatening ischemia, the most severe form of peripheral artery disease |
| Intermittent claudication (IC) | – | Diagnostic Test: Analysis of GLP-1 receptor expressionA group of patients presenting with intermittent claudication, a less advanced stage of of peripheral artery disease, serving as a comparator |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patients aged 40 years or older
- Documented Peripheral Artery Disease (PAD): Patients must fall into one of the two following severity groups:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of GLP-1 receptor expressionOne-time 15mL blood sampling for GLP-1R expression analysis on PBMCs via RT-qPCR and Western blot | Diagnostic test | Chronic Limb-Threatening Ischemia (CLTI), Intermittent claudication (IC) |
Primary outcome
Level of GLP-1 Receptor (GLP-1R) Gene Expression in PBMCs
Time frame: 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.
2 secondary outcomes
Systemic Pro-inflammatory Cytokine Profile
Time frame: Day 1
Oxidative and Nitrosative Stress Markers in PBMCs
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease (PAD) and Claudication, Intermittent, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of GLP-1 Receptor (GLP-1R) Gene Expression in PBMCs (time frame: Day 1 (at the time of the one-time blood sampling)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.