Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452862
• Other study ID #: ShengjingH-DKD
• Status: Recruiting
• Start date: May 5, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: June 2024
• Source: Shengjing Hospital
• Contact: Yu Shi, M.D.
• Phone: 18940259980
• Email: 18940259980[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2025
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosed diabetes
• No other diseases that affect renal function (such as gout, blood related diseases, primary hypertension, nephrotic syndrome, etc.),
• No contraindications for magnetic resonance imaging examination

Exclusion Criteria:

• Image quality does not meet the measurement requirements.
• Renal function damage caused by non-diabetes factors
• Combined with other important organ dysfunction
• Combined with malignant tumor
• Combined with other metabolic diseases anemia

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging
Both Diabetics 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, 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.

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging Evaluation of Kidney	To evaluate the ability of Multimodal Magnetic Resonance Imaging to identify and quantify the extent of of kidney damage. Regions of interest (ROIs) were placed manually in the renal cortex and medulla, avoiding renal hilar vessels and areas of obvious artifacts.	Baseline to 6 months