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NCT Number: NCT06586203

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Diabetic Nephropathy Type 2 Disease Attributes Disease Susceptibility Endocrine System Diseases Genetic Predisposition to Disease Genetic Risk Score Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUM, Montreal, Quebec, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Risk Prediction

Primary outcomes

  1. Composite endpoint consisting of HbA1c, SBP, albuminuria or GFR

    Time frame: Visit to visit up to 18 months

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

Secondary outcomes

  1. Medications for blood pressure, blood glucose and lipids

    Time frame: Visit to vist up to 18 months

    change of class or dosage

Other outcomes

  1. Microvascular and macrovascular endpoints

    Time frame: 18 months

    Macrovascular outcome comprises nonfatal stroke, nonfatal acute coronary syndrome and death from any cardiovascular cause. Microvascular endpoint comprises new or worsening nephropathy defined as the development of macroalbuminuria, doubling of serum creatinine, requirement for renal replacement therapy or death from renal disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Johanne Tremblay, PhD

CONTACT

[email protected]

514-890-8247

Marie-Renée Guertin, il,cra

CONTACT

[email protected]

514-249-4209

Sponsors and collaborators

Lead sponsor

Optithera

Industry

Collaborators

  • ELNA Medical
  • Genome Canada
  • Genome Quebec

Registry information

Official study title

New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes

Acronym: GENOCORDIA

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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