[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619091":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":10,"locations":24,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Chronic Limb-Threatening Ischemia (CLTI)",null,"A group of patients presenting with chronic limb-threatening ischemia, the most severe form of peripheral artery disease",[13],"Diagnostic Test: Analysis of GLP-1 receptor expression",{"label":15,"type":10,"description":16,"interventionNames":17},"Intermittent claudication (IC)","A group of patients presenting with intermittent claudication, a less advanced stage of of peripheral artery disease, serving as a comparator",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"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",[9,15],[25],{"facility":26,"status":10,"city":27,"state":10,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Hôpitaux Universitaires de Strasbourg","Strasbourg","67091","France","FR",{"type":32,"coordinates":33},"Point",[34,35],7.74553,48.58392,{"lat":35,"lon":34},[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Elena-Mihaela CORDEANU, MCU-PH","CONTACT","+33(0)369551520","+33","elena-mihaela.cordeanu@chru-strasbourg.fr",{"name":39,"role":45,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":50,"class":51},"Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118","UNKNOWN","100619091","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-100619091",false,"NCT07340112","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","EXCEL-CLTI","Inclusion Criteria:\n\n* Patients aged 40 years or older\n* Documented Peripheral Artery Disease (PAD): Patients must fall into one of the two following severity groups:\n\n  1. Intermittent Claudication (IC) Group: Defined by a maximum walking distance limited by intermittent claudication, associated with an Ankle-Brachial Index (ABI) \\\u003C 0.9 at rest.\n  2. Chronic Limb-Threatening Ischemia (CLTI) Group: Defined by ischemic rest pain and\u002For tissue loss (ulcers or gangrene) persisting for at least 15 days, associated with a toe pressure or a transcutaneous oxygen tension (tcPO2) \\\u003C 30 mmHg, according to the 2024 ESC guidelines.\n\nExclusion Criteria:\n\n* Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes\n* Current Specific Pharmacotherapy: Ongoing treatment with SGLT2 inhibitors (SGLT2i) or GLP-1 receptor agonists (GLP-1RA).\n* Infection: Presence of sepsis or an active systemic infection.\n* Malignancy: Active cancer or hematologic malignancies.\n* Immunosuppression: History of organ transplantation or autoimmune diseases currently requiring immunosuppressive therapy.\n* Known chronic inflammatory diseases.\n* Advanced Renal Failure: End-stage renal disease requiring dialysis.","ALL","40 Years",{"count":62,"type":63},50,"ESTIMATED","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.\n\nThe main questions it aims to answer are:\n\n* 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?\n* Is GLP1R expression associated with inflammatory and oxidative profiles of PBMC?\n* Can GLP-1 receptor agonists reverse inflammatory and oxidative alterations induced by plasma from patients with peripheral artery disease in endothelial cell cultures?\n* Are there specific plasma proteomic signatures associated with GLP1R overexpression?\n\nResearchers 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\u002Foxidative phenotype, and plasma proteomic profiles.\n\nParticipants will:\n\n* Provide an additional blood sample (15 mL) collected during a routine, clinically indicated blood draw\n* Have PBMC isolated for measurement of GLP1R expression and assessment of inflammatory and oxidative markers\n* Have plasma analyzed for proteomic profiling and used in in-vitro endothelial cell experiments\n\nParticipation ends after completion of the blood sampling, and no additional procedures beyond standard clinical care are required.",[67,68,69],"Peripheral Arterial Disease (PAD)","Claudication, Intermittent","Chronic Limb-Threatening Ischemia",[71,72,73,74],"Peripheral arterial disease","Chronic limb-threatening ischemia","GLP-1 receptor","Peripheral blood mononuclear cells (PBMC)","NOT_YET_RECRUITING","2026-01-05",{"date":78,"type":79},"2026-01-14","ACTUAL",{"date":81,"type":63},"2026-06",{"date":83,"type":63},"2028-06",{"name":5,"class":6},1]