Using a genetic test to manage heart and kidney complications in type 2 diabetes
New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes
NA · Optithera · NCT06586203
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2714 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Optithera (industry) |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT06586203 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients with type 2 diabetes, regardless of their current level of diabetes control or existing complications.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Montreal, Quebec and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetic Nephropathy Type 2, Cardiorenal complications, Polygenic risk scores, Therapeutic targets, Precision Medicine, Prevention