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MRI Biomarkers in Diabetic Kidney Disease

NCT ID: NCT04570735

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-07

Study Completion Date

2024-01-26

Brief Summary

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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

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Conditions

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Diabetic Nephropathies

Keywords

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obesity diabetic nephropathies biomarkers metabolites

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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patients with type 2 diabetes and diabetic kidney disease

MRI

Intervention Type DIAGNOSTIC_TEST

MRI

patients with type 2 diabetes and no diabetic kidney disease

MRI

Intervention Type DIAGNOSTIC_TEST

MRI

patients with obesity, no diabetes and no kidney disease

MRI

Intervention Type DIAGNOSTIC_TEST

MRI

Interventions

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MRI

MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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2019-A02750-57

Identifier Type: -

Identifier Source: org_study_id