Recruiting

Genomic Predictor Test

Sponsor:

Optithera

Code:

NCT06586203

Conditions

Diabetes Mellitus, Type 2

Cardiovascular Diseases

Diabetic Nephropathy Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Polygenic Risk Score

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

Cardiovascular Diseases

Diabetic Nephropathy Type 2

Study ID

NCT06586203

Start date

Aug 23, 2024

Status verified date

Sep, 2024

Completion date

Aug 23, 2028

Anticipated

Primary completion date

Aug 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2714 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Polygenic Risk Score

The Polygenic Risk Score (PRS) is a Class II software as a medical device (SaMD) that estimates a person's level of risk of developing a disease or associated complications before clinical signs appear. The device uses the genomic profile of the person in combination with some clinical data (i.e., age, sex, age of onset of diabetes) to compute this risk. This device further provides recommendations for personalized management of T2D for patients based on their risk score.

Primary outcome measure

  • Composite endpoint consisting of HbA1c, SBP, albuminuria or GFR [ Time Frame: Visit to visit up to 18 months ]

Central Contacts and Locations

Central contacts

Marie-Renée Guertin, il,cra

514-249-4209marie-renee.guertin.chum@ssss.gouv.qc.ca

Johanne Tremblay, PhD

514-890-8247johanne@optithera.onmicrosoft.com

Locations

CHUM

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Marie-Renée Guertin, Il, CRA

1-514-249-4209marie.renee.guertin.chum@ssss.gouv.qc.ca

Pavel Hamet, MD, PhD

1-514-862-2378

More Information

Sponsor

Optithera

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • Diabetes Mellitus, Type 2
  • Cardiorenal complications
  • Polygenic risk scores
  • Therapeutic targets
  • Precision Medicine
  • Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Optithera on 2024-09-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.