MRI Biomarkers in Diabetic Kidney Disease

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.

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Key information

Conditions

Diabetic Nephropathies Body Weight Diabetes Complications Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Diagnostic Test

MRI

Primary outcomes

Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups

Time frame: 1 month

Secondary outcomes

Association between MRS biomarkers and annual glomerural filtration rate slope calculated within 3 previous years

Time frame: 3 years
Correlation between metabolic MRS biomarkers and urine and plasma metabolites quantification.

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: MR3T - DKD

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2024
First posted: Sep 30, 2020
Registry last updated: Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed