Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586203
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENOCORDIA
Brief 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
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 70 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
B 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
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 70 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
B 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None