Status:
RECRUITING
Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
Lead Sponsor:
Optithera
Collaborating Sponsors:
Genome Quebec
Genome Canada
Conditions:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 h...
Detailed Description
Type 2 diabetes (T2D) increases the risk of developing serious cardiovascular and kidney complications that represent a major burden for both patients and our healthcare system. Currently, patients wi...
Eligibility Criteria
Inclusion
- Adult patients with T2D of both sexes regardless of ethnicity, level of diabetes control and presence of complications.
- Able to visit the study site 7 times
- Able and willing to provide informed consent to the clinical and PRS parts of the study.
Exclusion
- Any condition that may impact participation in a real-world study according to the treating physician.
- People with a high frailty index as no benefit of therapeutic intensification has been demonstrated in these diabetic patients.
- People who refuse to be informed of their cardiorenal risk score.
Key Trial Info
Start Date :
August 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 23 2028
Estimated Enrollment :
2714 Patients enrolled
Trial Details
Trial ID
NCT06586203
Start Date
August 23 2024
End Date
August 23 2028
Last Update
September 19 2024
Active Locations (2)
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1
CHUM
Montreal, Quebec, Canada, H2X 0A9
2
ELNA Medical
Montreal, Quebec, Canada, H3S 1Z5