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Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06452862
Enrollment
150
Registered
2024-06-11
Start date
2024-06-06
Completion date
2028-06-06
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Kidney Disease

Keywords

Diabetic Kidney Disease, Magnetic Resonance Imaging, Magnetic Resonance Elastography, Diabetes

Brief summary

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

Sponsors

Shengjing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Decline in Estimated Glomerular Filtration Rate (eGFR Slope)From enrollment to the end of follow-up at 24 monthsThe 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.

Countries

China

Contacts

CONTACTYu Shi, M.D.
18940259980@163.com18940259980
PRINCIPAL_INVESTIGATORYu Shi, M.D.

Shengjing Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026