NCT06586203Recruiting
Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2714 (estimated)
- First submitted
- 30 Aug 2024
- Start date
- 23 Aug 2024
- Primary completion date
- 23 Aug 2027
- Lead sponsor
- Optithera
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT06586203
What you commit to
- Study type: Interventional
- Planned participants: 2714
- From 23 Aug 2024 to the primary completion date, 23 Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition that may impact participation in a real-world study according to the treating physician.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| ELNA Medical Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.