NCT06586203 Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
| NCT ID | NCT06586203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Optithera |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,714 participants |
| Start Date | 2024-08-23 |
| Primary Completion | 2027-08-23 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,714 participants in total. It began in 2024-08-23 with a primary completion date of 2027-08-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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.
Contact & Investigator
Pavel Hamet, MD, PhD
PRINCIPAL INVESTIGATOR
CHUM
Frequently Asked Questions
Who can join the NCT06586203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06586203 currently recruiting?
Yes, NCT06586203 is actively recruiting participants. Contact the research team at marie-renee.guertin.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT06586203 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06586203 clinical trial?
NCT06586203 is sponsored by Optithera. The principal investigator is Pavel Hamet, MD, PhD at CHUM. The trial plans to enroll 2,714 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.