MRI Biomarkers in Diabetic Kidney Disease (MR3T - DKD)

January 28, 2021 updated by: Poitiers University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with type 2 diabetes and diabetic kidney disease
Diagnostic test: MRI
MRI
patients with type 2 diabetes and no diabetic kidney disease
Diagnostic test: MRI
MRI
patients with obesity, no diabetes and no kidney disease
Diagnostic test: MRI
MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between MRS biomarkers and annual glomerural filtration rate slope calculated within 3 previous years
Time Frame: 3 years
3 years
Correlation between metabolic MRS biomarkers and urine and plasma metabolites quantification.
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Anticipated)

October 7, 2021

Study Completion (Anticipated)

October 7, 2021

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02750-57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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