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MRI Biomarkers in Diabetic Kidney Disease (MR3T - DKD)

P

Poitiers University Hospital

Status

Completed

Conditions

Diabetic Nephropathies

Treatments

Diagnostic Test: MRI

Study type

Observational

Funder types

Other

Identifiers

NCT04570735
2019-A02750-57

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

patients with type 2 diabetes and diabetic kidney disease
Treatment:
Diagnostic Test: MRI
patients with type 2 diabetes and no diabetic kidney disease
Treatment:
Diagnostic Test: MRI
patients with obesity, no diabetes and no kidney disease
Treatment:
Diagnostic Test: MRI

Trial contacts and locations

1

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Central trial contact

Pierre Jean Saulnier, M.D. Ph.D.

Data sourced from clinicaltrials.gov

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