MRI Biomarkers in Diabetic Kidney Disease

NCT04570735 | Completed

• 1 other identifier: 2019-A02750-57
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathies

Keywords

obesity; diabetic nephropathies; biomarkers; metabolites

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (2)

• 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

Study Arms (3)

patients with type 2 diabetes and diabetic kidney disease

Diagnostic Test: MRI

patients with type 2 diabetes and no diabetic kidney disease

Diagnostic Test: MRI

patients with obesity, no diabetes and no kidney disease

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

MRI

patients with obesity, no diabetes and no kidney disease; patients with type 2 diabetes and diabetic kidney disease; patients with type 2 diabetes and no diabetic kidney disease

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes with or without diabetic kidney disease and patients with obesity and no diabetes

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 30, 2020
• Study Start: October 7, 2020
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)