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Genetic Test for Cardiorenal Complications in Type 2 Diabetes (GENOCORDIA Trial)

N/A
Recruiting
Led By Pavel Hamet, MD, PhD
Research Sponsored by Optithera
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to visit the study site 7 times
Be older than 18 years old
Must not have
People who refuse to be informed of their cardiorenal risk score
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if a genetic risk prediction test can help patients with Type 2 Diabetes avoid heart and kidney complications. Patients will be monitored over 18 months to see if knowing their risk helps

Who is the study for?
This trial is for individuals with Type 2 Diabetes who may also have cardiovascular disease or diabetic kidney disease. Participants will provide a saliva sample, attend clinic visits every three months, and complete quality of life questionnaires.
What is being tested?
The study tests if knowing one's genetic risk for cardiorenal complications (heart and kidney problems) from Type 2 Diabetes helps achieve better health targets over 18 months. This includes blood sugar levels, blood pressure, urine albumin levels, and kidney function.
What are the potential side effects?
Since the intervention involves only a polygenic risk score test based on saliva sampling without direct medication or invasive procedures, no direct side effects are expected from the test itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can visit the study site 7 times.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I refuse to know my heart and kidney risk score.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite endpoint consisting of HbA1c, SBP, albuminuria or GFR
Secondary study objectives
Medications for blood pressure, blood glucose and lipids
Other study objectives
Microvascular and macrovascular endpoints

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: InformedActive Control1 Intervention
Intervention group tested and informed of the Polygenic risk score test result at the start of the study
Group II: Not initially informedActive Control1 Intervention
Control group: tested but not informed of the Polygenic Risk Score test result at the start of the study.

Find a Location

Who is running the clinical trial?

ELNA MedicalUNKNOWN
Genome CanadaOTHER
16 Previous Clinical Trials
31,670 Total Patients Enrolled
Genome QuebecOTHER
7 Previous Clinical Trials
17,106 Total Patients Enrolled
~1809 spots leftby Aug 2027
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