Diabetes Mellitus, Type 2GENOCORDIANCT06586203
Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
A study testing Polygenic Risk Score in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Optithera at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetic Nephropathy Type 2
- What is being tested?
- Polygenic Risk Score
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,714 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Aug 2024to 23 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
CHUM
Montreal, Quebec, H2X 0A9
Marie-Renée Guertin, Il, CRA, 1-514-249-4209, marie.renee.guertin.chum@ssss.gouv.qc.ca
Pavel Hamet, MD, PhD, 1-514-862-2378
- Not yet recruiting
ELNA Medical
Montreal, Quebec, H3S 1Z5
Rose-Lyne Allouch, MD, 1-514-344-8022 ext. 275, rallouch@cdllabs.com
About this study
Official title: New GENOmic Predictor for COmplications Risk in 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.
Read more
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.
Read the detailed description
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.
- 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).
- Being tested
- Polygenic Risk Score
- Keywords
- Diabetes Mellitus, Type 2, Cardiorenal complications, Polygenic risk scores, Therapeutic targets, Precision Medicine, Prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygenic Risk ScoreDevice
Also called Risk Prediction
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.
| Study group | Role | What they receive |
|---|---|---|
| Informed | Active comparator | Intervention group tested and informed of the Polygenic risk score test result at the start of the study Receives: Device: Polygenic Risk Score |
| Not initially informed | No intervention | Control group: tested but not informed of the Polygenic Risk Score test result at the start of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit to visit up to 18 months
Secondary outcomes (1)
Medications for blood pressure, blood glucose and lipids
change of class or dosage
Measured: Visit to vist up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Aug 2024
- Primary completion23 Aug 2027 (estimated)
- Study completion23 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A) 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 Polygenic risk score test result. C) Adaptive trial for the treatment of subjects initially uninformed of their PRS test result after 12 months if positive results.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optithera
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genome Quebec, Genome Canada, ELNA Medical
- Responsible party
- Sponsor
- Investigators
- Pavel Hamet, MD, PhD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586203
- Sponsor's protocol ID
- OPT0003
- Acronym
- GENOCORDIA
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient data at the end of the study including risk strata.
Publications
Tremblay J, Haloui M, Attaoua R, Tahir R, Hishmih C, Harvey F, Marois-Blanchet FC, Long C, Simon P, Santucci L, Hizel C, Chalmers J, Marre M, Harrap S, Cifkova R, Krajcoviechova A, Matthews DR, Williams B, Poulter N, Zoungas S, Colagiuri S, Mancia G, Grobbee DE, Rodgers A, Liu L, Agbessi M, Bruat V, Fave MJ, Harwood MP, Awadalla P, Woodward M, Hussin JG, Hamet P. Polygenic risk scores predict diabetes complications and their response to intensive blood pressure and glucose control. Diabetologia. 2021 Sep;64(9):2012-2025. doi: 10.1007/s00125-021-05491-7. Epub 2021 Jul 6.
PubMed 34226943
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes
- ClinicalTrials.gov ID
- NCT06586203
- Acronym / sponsor ID
- GENOCORDIA / OPT0003
- Keywords
- Diabetes Mellitus, Type 2, Cardiorenal complications, Polygenic risk scores, Therapeutic targets, Precision Medicine, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,714 participants (estimated)
- Lead sponsor
- OptitheraIndustry (pharma, biotech, devices)
- Collaborators
- Genome Quebec, Genome Canada, ELNA Medical
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 23 Aug 2027 (estimated)
- Study completion
- 23 Aug 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A) 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 Polygenic risk score test result. C) Adaptive trial for the treatment of subjects initially uninformed of their PRS test result after 12 months if positive results.
| Arm | Type | Receives |
|---|---|---|
| Informed | Active comparator | Device: Polygenic Risk ScoreIntervention group tested and informed of the Polygenic risk score test result at the start of the study |
| Not initially informed | No intervention | –Control group: tested but not informed of the Polygenic Risk Score test result at the start of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygenic Risk ScoreAlso: Risk PredictionThe 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. | Device | Informed |
Primary outcome
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.
1 secondary outcome
Medications for blood pressure, blood glucose and lipids
Time frame: Visit to vist up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 34226943Tremblay J, Haloui M, Attaoua R, Tahir R, Hishmih C, Harvey F, Marois-Blanchet FC, Long C, Simon P, Santucci L, Hizel C, Chalmers J, Marre M, Harrap S, Cifkova R, Krajcoviechova A, Matthews DR, Williams B, Poulter N, Zoungas S, Colagiuri S, Mancia G, Grobbee DE, Rodgers A, Liu L, Agbessi M, Bruat V, Fave MJ, Harwood MP, Awadalla P, Woodward M, Hussin JG, Hamet P. Polygenic risk scores predict diabetes complications and their response to intensive blood pressure and glucose control. Diabetologia. 2021 Sep;64(9):2012-2025. doi: 10.1007/s00125-021-05491-7. Epub 2021 Jul 6.
- Individual participant dataSharing planned: Yes. De-identified patient data at the end of the study including risk strata.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pavel Hamet, MD, PhD principal investigator
CHUM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygenic Risk Score in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Optithera at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Renée Guertin, il,cra (514-249-4209, marie-renee.guertin.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint consisting of HbA1c, SBP, albuminuria or GFR (time frame: Visit to visit up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06586203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.