Using a genetic test to manage heart and kidney complications in type 2 diabetes
Official title: New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes
Run by Optithera · NCT06586203 · Data updated 2026-11-12
This study is testing if a genetic test can help doctors better manage heart and kidney problems in people with type 2 diabetes by personalizing their treatment based on their genetic risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2714 (estimated) |
| Sponsor | Optithera Industry-sponsored |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Status | Recruiting |
| Started | August 23, 2024 |
| Main results expected | August 23, 2027 |
| Study ends | August 23, 2028 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT06586203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients with type 2 diabetes, regardless of their current level of diabetes control or existing complications.
✕Probably not a fit
Patients with a high frailty index or those who refuse to be informed of their cardiorenal risk score may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pragmatic trial aims to evaluate the effectiveness of a polygenic risk prediction test in managing cardiorenal complications in patients with type 2 diabetes (T2D). Participants will undergo saliva sampling to determine their genetic risk and will have regular clinic visits every three months for checkups and tests. The study will compare the achievement of therapeutic targets between patients who are informed of their genetic risk and those who are not, over an 18-month period. The goal is to improve management of blood glucose, blood pressure, and kidney function in high-risk patients through personalized treatment approaches.
Why it matters
Potential benefit: If successful, this approach could lead to better management of cardiovascular and kidney complications in patients with type 2 diabetes.
How similar studies have gone: While the use of polygenic risk scores in diabetes management is an emerging field, this specific approach is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
-
Chum
Montreal, Quebec, Canada Recruiting -
ELNA Medical
Montreal, Quebec, Canada Not yet recruiting
Study contacts
- Principal investigator: Pavel Hamet, MD, PhD — Chum
- Study coordinator: Marie-Renée Guertin, il,cra
- Email: marie-renee.guertin.chum@ssss.gouv.qc.ca
- Phone: 514-249-4209
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.