[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561134":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":76,"collaborators":78,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":18,"enrollmentInfo":96,"targetDuration":18,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Optithera","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Informed","ACTIVE_COMPARATOR","Intervention group tested and informed of the Polygenic risk score test result at the start of the study",[13],"Device: Polygenic Risk Score",{"label":15,"type":16,"description":17,"interventionNames":18},"Not initially informed","NO_INTERVENTION","Control group: tested but not informed of the Polygenic Risk Score test result at the start of the study.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Polygenic Risk Score","The Polygenic Risk Score (PRS) is a Class II software as a medical device (SaMD) that estimates a person's level of risk of developing a disease or associated complications before clinical signs appear. The device uses the genomic profile of the person in combination with some clinical data (i.e., age, sex, age of onset of diabetes) to compute this risk. This device further provides recommendations for personalized management of T2D for patients based on their risk score.",[9],[26],"Risk Prediction",[28],{"name":29,"affiliation":30,"role":31},"Pavel Hamet, MD, PhD","CHUM","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Marie-Renée Guertin, il,cra","CONTACT","514-249-4209","marie-renee.guertin.chum@ssss.gouv.qc.ca",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"Johanne Tremblay, PhD","514-890-8247","johanne@optithera.onmicrosoft.com",[43,63],{"facility":30,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Montreal","Quebec","H2X 0A9","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-73.58781,45.50884,{"lat":54,"lon":53},[57,61],{"name":58,"role":35,"phone":59,"phoneExt":18,"email":60},"Marie-Renée Guertin, Il, CRA","1-514-249-4209","marie.renee.guertin.chum@ssss.gouv.qc.ca",{"name":29,"role":35,"phone":62,"phoneExt":18,"email":18},"1-514-862-2378",{"facility":64,"status":65,"city":45,"state":46,"zip":66,"country":48,"countryCode":49,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"ELNA Medical","NOT_YET_RECRUITING","H3S 1Z5",{"type":51,"coordinates":68},[53,54],{"lat":54,"lon":53},[71],{"name":72,"role":35,"phone":73,"phoneExt":74,"email":75},"Rose-Lyne Allouch, MD","1-514-344-8022","275","rallouch@cdllabs.com",{"type":77,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[79,82,84],{"name":80,"class":81},"Genome Quebec","OTHER",{"name":83,"class":81},"Genome Canada",{"name":64,"class":85},"UNKNOWN","100561134","clinical-utility-of-a-genomic-predictor-test-on-the-management-of-cardiorenal-complications-of-type-2-diabetes-100561134",false,"NCT06586203","Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes","New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes","GENOCORDIA","Inclusion Criteria:\n\n* Adult patients with T2D of both sexes regardless of ethnicity, level of diabetes control and presence of complications.\n* Able to visit the study site 7 times\n* Able and willing to provide informed consent to the clinical and PRS parts of the study.\n\nExclusion Criteria:\n\n* Any condition that may impact participation in a real-world study according to the treating physician.\n* People with a high frailty index as no benefit of therapeutic intensification has been demonstrated in these diabetic patients.\n* People who refuse to be informed of their cardiorenal risk score.","ALL","18 Years",{"count":97,"type":98},2714,"ESTIMATED","INTERVENTIONAL",[101],"NA","The goal of this pragmatic trial is to provide Real World Evidence (RWE) on the impact of the result of a polygenic risk prediction test of cardiorenal complications of T2D, so that more patients at high risk of these complications achieve over an 18 months period, recommended therapeutic targets.\n\nThis will be demonstrated as a significant improvement in a composite value including HbA1c or systolic blood pressure (SBP) or albuminuria (UACR), or glomerular filtration rate (GFR) lowering.\n\nResearchers will compare the recommended therapeutic targets of uninformed and informed patients to see if the knowledge of the risk by the patients and their treating physicians improves achievement of these targets.\n\nParticipants will:\n\nHave a saliva sampling to determine the genetic risk. Visit the clinic once every 3 months for checkups and tests Answer two questionnaires on quality of life.",[104,105,106],"Diabetes Mellitus, Type 2","Cardiovascular Diseases","Diabetic Nephropathy Type 2",[104,108,109,110,111,112],"Cardiorenal complications","Polygenic risk scores","Therapeutic targets","Precision Medicine","Prevention","2024-09-05",{"date":115,"type":116},"2024-09-19","ACTUAL",{"date":118,"type":116},"2024-08-23",{"date":120,"type":98},"2028-08-23",{"name":5,"class":6},2]