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

NCT06586203 | Recruiting DMC

• 1 other identifier: OPT0003
• Study Type: interventional
• Target: 2,714
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite endpoint consisting of HbA1c, SBP, albuminuria or GFR

  Change of HbA1c, or SBP or albuminuria stage or eGFR decline. Percent of participants at therapeutic targets.

  Visit to visit up to 18 months

Secondary Outcomes (1)

• Medications for blood pressure, blood glucose and lipids

  Visit to vist up to 18 months

Other Outcomes (1)

• Microvascular and macrovascular endpoints

  18 months

Study Arms (2)

Informed

ACTIVE COMPARATOR

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

Device: Polygenic Risk Score

Not initially informed

NO INTERVENTION

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

Interventions

Polygenic Risk Score 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.

Also known as: Risk Prediction

Informed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Optithera: lead
• Genome Quebec: collaborator
• Genome Canada: collaborator
• ELNA Medical: collaborator

Study Sites (2)

CHUM

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

ELNA Medical

Montreal, Quebec, H3S 1Z5, Canada

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 34226943 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Genetic Risk Score

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pavel Hamet, MD, PhD

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Renée Guertin, il,cra

CONTACT

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

Johanne Tremblay, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A) 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 Polygenic risk score test result. C) Adaptive trial for the treatment of subjects initially uninformed of their PRS test result after 12 months if positive results.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): August 23, 2027
• Study Completion (Estimated): August 23, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Six months after study publication.
• Access Criteria: Contact the PI.

Locations

CA (2)