Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOptithera
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Polygenic Risk Score
DeviceThe 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.
Treatment groups
2,714 Participants
are divided into 2 treatment groupsGroup A: InformedActive comparator 1 intervention
Group B: Not initially informedNo intervention 0 interventions
Trial outcomes
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.
Time frame
Visit to visit up to 18 monthsSecondary outcomes
1
Medications for blood pressure, blood glucose and lipids
change of class or dosage
Time frame
Visit to vist up to 18 monthsOther outcomes
1
Microvascular and macrovascular endpoints
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.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov