NCT04570735已完成不适用
MRI Biomarkers in Diabetic Kidney Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups
研究概览
简要总结
Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Therefor there is an uncovered need to identify complementary biomarkers. Magnetic Resonance Spectroscopy (MRS) is a Magnetic Resonance Imaging (MRI) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Common to all 3 category
- •Male or female,
- •Age≥ 35 years,
- •Subject free, with legal protection guardianship or curatorship;
- •Enrollment in the French Social Security system;
- •Informed consent signed by the patient
- •Obese patients
- •BMI >30 kgm² ;
- •With no known diabetes;
- •estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73m² and urine albumin-creatinin ratio (ACR) < 3 mg/g
- •Type 2 diabetic patients without kidney disease
- •eGFR > 60 ml/min/1.73m² AND ACR < 3 mg/g,
- •Type 2 diabetic patients with diabetic kidney disease defined as eGFR 30 to 60 ml/min/1.73m² OR ACR > 30 mg/mmol.
排除标准
- •Age < 35 years History of kidney transplant Any contraindication to an MRI examination Legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations Pregnant or lactating women, women of childbearing age who do not have effective contraception
结局指标
主要结局
Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups
时间窗: 1 month
次要结局
- Association between MRS biomarkers and annual glomerural filtration rate slope calculated within 3 previous years(3 years)
- Correlation between metabolic MRS biomarkers and urine and plasma metabolites quantification.(1 month)
研究者
研究点 (1)
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