New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
CHUM
RECRUITING
Montreal
ELNA Medical
NOT_YET_RECRUITING
Montreal
Contact Information
Primary
Marie-Renée Guertin, il,cra
marie-renee.guertin.chum@ssss.gouv.qc.ca
514-249-4209
Backup
Johanne Tremblay, PhD
johanne@optithera.onmicrosoft.com
514-890-8247
Time Frame
Start Date: 2024-08-23
Estimated Completion Date: 2028-08-23
Participants
Target number of participants: 2714
Treatments
Active_comparator: Informed
Intervention group tested and informed of the Polygenic risk score test result at the start of the study
No_intervention: Not initially informed
Control group: tested but not informed of the Polygenic Risk Score test result at the start of the study.
Sponsors
Collaborators: ELNA Medical, Genome Quebec, Genome Canada
Leads: Optithera

This content was sourced from clinicaltrials.gov