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Recruiting NCT06452862

Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease

Observational Diabetic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Diabetic Kidney Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

the Value of Multimodal Magnetic Resonance Imaging in the Diagnosis and Treatment Monitoring of Diabetic Kidney Disease

Overview

The goal of this study is to investigate the value of noninvasive evaluation of multimodal magnetic resonance imaging in diagnosis and treatment of diabetic kidney disease (DKD). We aim to explore the feasibility of multimodal magnetic resonance imaging in the staging diagnosis of DKD, and establish a non-invasive method for evaluating the progression of DKD disease by combining imaging and biochemical indicators. Multimodal magnetic resonance examinations will be performed on diabetic patients with different stages as well as regular follow-up during treatment, in order to investigate the relationship between imaging findings and pathophysiological changes of the kidneys.

Detailed description

At present, the clinical diagnosis of diabetic kidney disease (DKD) relies mainly on the detection of urine microalbumin,which is influenced by many other factors. Renal biopsy is another modality to detect DKD, but it cannot be widely used in clinical practice because of its invasiveness. Thus, a reproducible and reliable noninvasive method is needed for more accurate diagnosis.

Multimodal magnetic resonance imaging, which including but not limited to magnetic resonance elastography (MRE), blood oxygen level-dependent magnetic resonance imaging (BOLD-MRI), arterial spin labeling (ASL), incoherent motion diffusion-weighted imaging (IVIM-DWI), T1mapping and T2mapping, is able to provide valuable information about subtle structural and functional changes, and has shown promising potential in the diagnosis, classification and prediction of pathological and molecular features.

In this clinical trial, multimodal magnetic resonance examinations will be performed on diabetic patients with different stages as well as regular follow-up during treatment, in order to investigate the relationship between imaging findings and pathophysiological changes of the kidneys. We aim to explore the feasibility of multimodal magnetic resonance imaging in the staging diagnosis of DKD and establish a non-invasive method for evaluating the progression of DKD disease by combining imaging and biochemical indicators, in order to provide reference for clinical medication. This research could be helpful for better understanding and management of DKD, and pave the way for more accurate diagnosis, improved clinical decision-making, personalized treatment approaches for DKD patients.

Interventions

  • Diagnostic test Magnetic Resonance Imaging
    Both Diabetic Kidney Disease (DKD) patients and Healthy Volunteers will undergo MRI protocols including Blood Oxygen Level Dependence (BOLD), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1\&T2-mapping imaging and Magnetic Resonance Elastography (MRE). For Diabetics, blood tests for creatinine and cystatin C, urine test for albumin-to-creatinine ratio (UACR), along with blood pressure measurements, will be taken within a three-day window surrounding the MRE test. Additional

Primary outcome measures

  • Rate of Decline in Estimated Glomerular Filtration Rate (eGFR Slope) [Time frame: From enrollment to the end of follow-up at 24 months]

Eligibility criteria

Inclusion criteria

  • Clinically diagnosed diabetic kidney disease (DKD)
  • Age 18-80 years

Exclusion criteria

  • Malignant tumor, active infection, or life expectancy <1 year
  • Pregnancy or lactation
  • MRE contraindications (metal implants, claustrophobia, severe arrhythmia) or poor image quality
  • eGFR <15 mL/min/1.73m² or receiving renal replacement therapy
  • Other primary kidney diseases or systemic diseases affecting renal function

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shengjing Hospital — Shenyang

Publications

  • Brown RS, Sun MRM, Stillman IE, Russell TL, Rosas SE, Wei JL. The utility of magnetic resonance imaging for noninvasive evaluation of diabetic nephropathy. Nephrol Dial Transplant. 2020 Jun 1;35(6):970-978. doi: 10.1093/ndt/gfz066. PMID 31329940

Identifiers

NCT: NCT06452862 · ShengjingH-DKD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗