MRI Biomarkers in Diabetic Kidney Disease
- Conditions
- Diabetic Nephropathies
- Registration Number
- NCT04570735
- Lead Sponsor
- Poitiers University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups 1 month
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
CHU de Poitiers
🇫🇷Poitiers, France
CHU de Poitiers🇫🇷Poitiers, France