MRI Biomarkers in Diabetic Kidney Disease

Diabetic Nephropathies Clinical Trial

— MR3T - DKD  

Official title:

MRI Biomarkers in Diabetic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570735
• Other study ID #: 2019-A02750-57
• Status: Recruiting
• Start date: October 7, 2020
• Est. completion date: October 7, 2021

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: Pierre Jean Saulnier, M.D. Ph.D.
• Phone: +33 5 49 44 46 89
• Email: pierre-jean.saulnier[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Diagnostic Test:
• MRI
MRI

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups		1 month
Secondary	Association between MRS biomarkers and annual glomerural filtration rate slope calculated within 3 previous years		3 years
Secondary	Correlation between metabolic MRS biomarkers and urine and plasma metabolites quantification.		1 month