Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes

NCT ID: NCT06586203

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2714 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-23
• Study Completion Date: 2028-08-23

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.

Detailed Description

Type 2 diabetes (T2D) increases the risk of developing serious cardiovascular and kidney complications that represent a major burden for both patients and our healthcare system. Currently, patients with T2D are treated according to guidelines, with varied results in terms of systolic blood pressure (SBP), blood glucose (HbA1c), urine albumin-creatinine ratio (UACR) and glomerular filtration rate (GFR) target achievement.

OPTITHERA has developed the first genomic test to predict the risk of cardiorenal complications that will allow early and personalized treatment of patients with T2D who are at high risk using Polygenic risk score.

It is proposed that knowledge of the risk of developing complications of diabetes will have a positive effect on the care pathway of diabetic patients: the patient will be able to actively participate in their care and their doctor will be able to adapt his treatment to his personal risk, especially if his patient is at high risk of complications.

Objective: To provide Real World Evidence (RWE) on the impact of the result of a PRS prediction test on the risk of complications of T2D, so that patients at high risk of complications achieve, over an 18-month period, recommended targets for systolic blood pressure (≤130 mmHg) or HbA1c (<7.0%), or decreased albuminuria grade, GFR decline, while avoiding severe hypoglycemia and falls.

This will be demonstrated as a significant improvement in composite value including HbA1c or systolic blood pressure (SBP) or albuminuria (UACR).

Methodology: Multicenter Study: A) Pragmatic trial designed to evaluate the effectiveness of GENOCORDIA PRS testing in real-life routine practice conditions.

B) Randomization of participants into informed and uninformed populations of the PRS test result. C) Adaptive trial for the treatment of subjects initially uninformed of their PRS test result.

Estimated number of participants: 2714 participants randomized into two groups. Estimated study enrollment duration= 9 months. Estimated total study duration = 36 months. 18 months follow-up (7 visits).

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Diabetic Nephropathy Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Informed

Intervention group tested and informed of the Polygenic risk score test result at the start of the study

Group Type: ACTIVE_COMPARATOR

Polygenic Risk Score

Intervention Type: DEVICE

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.

Not initially informed

Control group: tested but not informed of the Polygenic Risk Score test result at the start of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: DEVICE

Other Intervention Names

Risk Prediction

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genome Quebec

OTHER

Sponsor Role: collaborator

Genome Canada

OTHER

Sponsor Role: collaborator

ELNA Medical

UNKNOWN

Sponsor Role: collaborator

Optithera

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavel Hamet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

CHUM

Montreal, Quebec, Canada

Site Status: RECRUITING

ELNA Medical

Montreal, Quebec, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Marie-Renée Guertin, il,cra

Role: CONTACT

marie-renee.guertin.chum@ssss.gouv.qc.ca

514-249-4209

Johanne Tremblay, PhD

Role: CONTACT

johanne@optithera.onmicrosoft.com

514-890-8247

Facility Contacts

Marie-Renée Guertin, Il, CRA

Role: primary

marie.renee.guertin.chum@ssss.gouv.qc.ca

1-514-249-4209

Pavel Hamet, MD, PhD

Role: backup

1-514-862-2378

Rose-Lyne Allouch, MD

Role: primary

rallouch@cdllabs.com

1-514-344-8022 ext. 275

References

Tremblay J, Haloui M, Attaoua R, Tahir R, Hishmih C, Harvey F, Marois-Blanchet FC, Long C, Simon P, Santucci L, Hizel C, Chalmers J, Marre M, Harrap S, Cifkova R, Krajcoviechova A, Matthews DR, Williams B, Poulter N, Zoungas S, Colagiuri S, Mancia G, Grobbee DE, Rodgers A, Liu L, Agbessi M, Bruat V, Fave MJ, Harwood MP, Awadalla P, Woodward M, Hussin JG, Hamet P. Polygenic risk scores predict diabetes complications and their response to intensive blood pressure and glucose control. Diabetologia. 2021 Sep;64(9):2012-2025. doi: 10.1007/s00125-021-05491-7. Epub 2021 Jul 6.

Reference Type: BACKGROUND

PMID: 34226943 (View on PubMed)

Other Identifiers

OPT0003

Identifier Type: -

Identifier Source: org_study_id