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NCT Number: NCT06452862

Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

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. Additionally, Diabetics will undergo a renal biopsy to assess the extent of kidney damage.

Primary outcomes

  1. Rate of Decline in Estimated Glomerular Filtration Rate (eGFR Slope)

    Time frame: From enrollment to the end of follow-up at 24 months

    The primary outcome is the rate of change in estimated glomerular filtration rate (eGFR), calculated using serum creatinine and cystatin C, expressed as eGFR slope (mL/min/1.73m² per year). eGFR will be measured at baseline and 6 months to assess kidney function decline. Baseline multimodal MRI parameters (BOLD, IVIM, ASL, T1/T2 mapping, MRE) will be evaluated for their ability to predict subsequent eGFR decline.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Shi, M.D.

CONTACT

[email protected]

18940259980

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 11, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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