MRI Biomarkers in Diabetic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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MRI Biomarkers in Diabetic Kidney Disease

Conditions
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Diabetic Nephropathies

Intervention / Treatment
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* Diagnostic Test: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with type 2 diabetes and diabetic kidney disease<br> | Diagnostic Test: MRI<br>* MRI<br>|
| patients with type 2 diabetes and no diabetic kidney disease<br> | Diagnostic Test: MRI<br>* MRI<br>|
| patients with obesity, no diabetes and no kidney disease<br> | Diagnostic Test: MRI<br>* MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, diabetic nephropathies, biomarkers, metabolites