Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOptithera
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Polygenic Risk Score
Treatment groups
2,714 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov