Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Cardiovascular Diseases trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment2714 (estimated)
SponsorOptithera
Industry-sponsored
Locations2 sites (Montreal, Quebec and 1 other locations)
StatusRecruiting
StartedAugust 23, 2024
Main results expectedAugust 23, 2027
Study endsAugust 23, 2028
Registry record updatedSeptember 19, 2024
Trial IDNCT06586203 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.