RecruitingNot ApplicableNCT06586203

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

New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes

Sponsor

Optithera

Enrollment

2,714 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Diabetes Mellitus, Type 2 Diabetic Nephropathy Type 2

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether a genetic risk test can help doctors better manage heart and kidney complications in people with type 2 diabetes. You may be eligible if... - You are an adult with type 2 diabetes, regardless of ethnicity, how well your diabetes is controlled, or whether you already have complications - You are able and willing to visit the study site 7 times - You are willing to consent to both the clinical and genetic parts of the study You may NOT be eligible if... - Your doctor thinks any condition you have would affect your ability to participate - You have a high frailty level (very frail patients are excluded since intensified treatment has not been shown to benefit them) - You do not want to be told your heart and kidney risk score Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPolygenic 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.