RecruitingNAINTERVENTIONAL

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

This study aims to discover if knowing your genetic risk for heart and kidney problems, if you have type 2 diabetes, helps you and your doctor manage your health better. Researchers are using a special genetic test called a Polygenic Risk Score. Participants will provide a saliva sample and have check-ups every three months for 18 months, answering questions about their quality of life. The goal is to see if people who know their risk score achieve their recommended health targets, like blood sugar or blood pressure levels, more effectively than those who don't. This research could help doctors offer more tailored treatment to people at higher risk of these complications.

At a glance

Status

Recruiting

Phase

Sponsor

Optithera

Enrolment target

2,714

Start

23 Aug 2024

Estimated completion

23 Aug 2028

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetic Nephropathy Type 2

What is this study about?

If you have type 2 diabetes, you're at a higher risk of developing serious heart and kidney problems. These complications can greatly affect your health and put a strain on our healthcare system. Currently, doctors follow general guidelines to treat people with type 2 diabetes, but how well these treatments work can vary from person to person. This study is looking into a new genetic test that can predict your personal risk of developing these complications.

This genetic test helps to understand if you are more likely to develop certain heart and kidney issues. The researchers want to see if knowing this personal risk helps you and your doctor make better decisions about your care. The idea is that if you know you're at a higher risk, you might be more motivated to actively manage your health, and your doctor might adjust your treatment to better suit your individual needs.

The main goal of this study is to provide real-world evidence. This means they want to see if people who know their risk score are more successful in reaching important health targets over an 18-month period. These targets include things like controlling blood sugar (HbA1c), keeping blood pressure in a healthy range, or improving markers related to kidney health. By comparing outcomes between those who know their risk and those who don't, the study hopes to show if this genetic test can lead to more effective and personalised care for people with type 2 diabetes.

Key takeaways

It's about whether knowing your genetic risk for heart/kidney issues helps manage type 2 diabetes.
You'll provide a saliva sample for genetic testing.
There will be check-up visits every 3 months for 18 months.
The study compares people who know their genetic risk with those who don't.
It aims to see if knowing your risk helps you reach health goals like blood sugar and blood pressure targets.

Who may be eligible?

To join this study, you need to be an adult with type 2 diabetes. Your gender, background, how well your diabetes is currently controlled, or whether you already have some complications, don't matter for joining.

You must be able to attend the study clinic seven times over the study period and be willing to give your informed consent, which means you understand what the study involves and agree to take part in both the health check-ups and the genetic testing.

However, you might not be able to join if your doctor believes another health condition could make it difficult for you to participate fully. Also, if you are very frail, you might not be eligible. Finally, if you would prefer not to know your genetic risk score for heart and kidney problems, this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult with type 2 diabetes?
Can you attend 7 visits to the clinic over 18 months?
Are you willing to provide a saliva sample?
Are you comfortable potentially being told your genetic risk score?
Do you feel generally well enough to participate in a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be asked to provide a saliva sample to help determine your genetic risk. You will attend the clinic for check-ups once every three months over an 18-month period, making it a total of seven visits. During these visits, you'll have various tests done, and you will also be asked to complete two questionnaires about your quality of life. The study aims to compare what happens when some people are told their genetic risk score and others are not, to see how this knowledge affects health outcomes and treatment decisions. Your current medication and general treatment will continue as advised by your doctor, but the study will observe if knowing your risk score influences treatment adjustments.

Potential risks and benefits

Participating in this study might offer you the benefit of better understanding your personal risk of heart and kidney problems, potentially leading to more tailored care. By actively monitoring your health, you could achieve recommended treatment targets more effectively. As with any study, there's always a small chance of unforeseen risks, but the study processes are designed to be safe and monitored by medical professionals. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

CHUM
Verified postcode
Montreal, Canada· Recruiting
ELNA Medical
Verified postcode
Montreal, Canada· Not yet recruiting

Common questions

What is a 'genetic risk score'?

It's a special score based on your genes (from a saliva sample) that helps tell how likely you are to develop certain health problems, like heart or kidney issues, if you have type 2 diabetes.

How long will the study last if I join?

The study will last for 18 months, during which you will have check-ups every three months.

Will I find out my genetic risk score?

Some participants will be told their score, and some won't. This is how the study plans to compare the effects of knowing your risk.

What kind of tests will I have?

You'll have regular medical check-ups and tests, likely similar to what you already have for diabetes. You'll also provide a saliva sample for the genetic test.

Will my regular diabetes treatment change?

Your doctor will continue to manage your care. The study aims to see if knowing your genetic risk helps you and your doctor make informed decisions about your treatment.

How to find out more

Marie-Renée Guertin, il,cra

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

Always speak to your GP or specialist before deciding to take part in a study.