New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,714
- 试验地点
- 4
- 主要终点
- Composite endpoint consisting of HbA1c, SBP, albuminuria or GFR
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Composite endpoint consisting of HbA1c, SBP, albuminuria or GFR
时间窗: Visit to visit up to 18 months
Change of HbA1c, or SBP or albuminuria stage or eGFR decline. Percent of participants at therapeutic targets.
次要结局
- Medications for blood pressure, blood glucose and lipids(Visit to vist up to 18 months)