MRI Biomarkers in Diabetic Kidney Disease

Completed

• Conditions: Diabetic Nephropathies
• Interventions: Diagnostic Test: MRI

• 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

Study Timeline

• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Study Start: 2020-10-07
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with type 2 diabetes and diabetic kidney disease	MRI	-
patients with type 2 diabetes and no diabetic kidney disease	MRI	-
patients with obesity, no diabetes and no kidney disease	MRI	-

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