Precision Medicine Approach to Unravel the Risk Factors for Renal, Cardiovascular, Ophthalmologic, Neurologic and Hepatic Complications of Metabolic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- the rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance
研究概览
简要总结
There is currently no way to predict the progression of chronic kidney disease in patients with metabolic disease(s). Furthermore, the mechanisms responsible for the development and/or progression of complications remain largely unknown.
In order to identify the predictive factors and/or mechanisms involved in the different complications of these diseases, we propose an approach coupling :
- a classical phenotypic characterization (clinical, biological, imaging) of the patients
- high-throughput screening of the genome, transcriptome, metabolome, proteome, and immunophenotyping.
According to our hypothesis, this approach should allow :
- Early detection of complications
- Classification of patients in homogeneous groups of patients with identical evolution
- Identification of the molecular mechanisms involved.
详细描述
Eligible patients will be detected during one of their consultations at the precision medicine center of the Amiens-Picardy University Hospital. They will be informed of the proposed research pathway during a care consultation. After a period of reflection, patients who accept this pathway will be included and a written consent form will be collected.
The inclusion visit will be scheduled at the precision medicine center of the Amiens-Picardy University Hospital and will take place during a day hospital (HDJ) which is part of a routine care pathway (neurological, cardiovascular, hepatic and renal primary prevention). At the time of inclusion, the informed consent will be signed by the investigator as well as by the patient The collection of data obtained during the patient's routine care will be performed by a physician from the Precision Medicine Center and a clinical research nurse and will be recorded in the patient's medical record.
Biological samples for the research (additional blood volume, urine) will be taken in conjunction with those for the routine check-up.
A hair strand of approximately 100 hairs (approx. 2 mm diameter) will be collected at the inclusion visit. This sample will be optional and will be subject to a specific authorization from the patient on the consent form.
Biological samples intended for research will be sent by the department's staff to the Biobank of Picardie (CHU Amiens-Picardie) for processing and storage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult persons, male or female, age ≥ 18 and ≤ 65 years
- •Persons able to understand the information provided and to object to it (at the discretion of the investigator)
- •Patient affiliated to a social security system.
- •Patient willing to sign an informed consent form
- •Patient with the following metabolic profile Diabetic (of any type) treated or not (diabetes will be defined by a fasting blood glucose > 7mM or a HbA1c > 6.5% or by the use of an antidiabetic treatment) AND/OR Obese patient (BMI > 30 kg/m2) treated or not
- •Patient with evidence of renal parenchymal damage defined by an albuminuria/creatinuria ratio ≥ 3 mg/mmol (30mg/g), AND/OR a glomerular filtration rate estimated by the CKD-EPI (eDFG) formula classifying the patient as stage 2 to 3a of the KDIGO classification (i.e., 90ml/min/1.73 m2 > GFR > 45ml/min), AND/OR a renal lithiasis
排除标准
- •Patient deprived of liberty
- •Person subject to a legal protection measure (guardianship, curatorship or safeguard of justice)
- •Patient refusing to participate in the study
- •Pregnant, parturient or nursing woman
- •Patient in emergency situation
- •Patient with advanced chronic kidney disease defined as GFR < 45ml/min/1.73 m².
- •Contraindication to Iohexol injection
- •Patient with or who has had any of the following complications: symptomatic coronary artery disease, symptomatic peripheral arterial disease, previous stroke, previous myocardial infarction, heart failure ≥ stage B, dementia, liver fibrosis, hepatocarcinoma.
结局指标
主要结局
the rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance
时间窗: from day 1 of inclusion, up to 7 years
The rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance, which will distinguish three groups of patients: * Those with physiological (age-related) annual decline: \<2ml/min per 1.73 m²/year (non-progressors), * Those with moderate annual decline ≥2 and \<5 ml/min per 1.73 m²/year (moderate progressors) * Those with rapid annual decline ≥5 ml/min per 1.73 m²/year (rapid progressors)
次要结局
- microvascular event(from day 1 of inclusion, up to 7 years)
- The occurrence of severe liver damage(from day 1 of inclusion, up to 7 years)
- Major cardiovascular event(from day 1 of inclusion, up to 7 years)
- The evolution of vascular status(from day 1 of inclusion, up to 7 years)
- Cognitive performance(from day 1 of inclusion, up to 7 years)
- The onset of dementia defined as a cognitive disorder(from day 1 of inclusion, up to 7 years)