Actively Recruiting
Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
Led by Optithera · Updated on 2024-09-19
2714
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
O
Optithera
Lead Sponsor
G
Genome Quebec
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. This 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. Researchers 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. Participants will: Have 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.
CONDITIONS
Official Title
Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with type 2 diabetes of any sex and ethnicity
- Able to visit the study site 7 times
- Able and willing to provide informed consent for the clinical and genetic parts of the study
You will not qualify if you...
- Any condition that may affect participation in a real-world study as judged by the treating physician
- High frailty index where therapeutic intensification has no proven benefit
- People who refuse to be informed of their cardiorenal risk score
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CHUM
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
2
ELNA Medical
Montreal, Quebec, Canada, H3S 1Z5
Not Yet Recruiting
Research Team
M
Marie-Renée Guertin, il,cra
CONTACT
J
Johanne Tremblay, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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