Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2026-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetics

Participants with diagnosed Diabetes will undergo the same MRI protocol as the Healthy Volunteers, including Blood Oxygen Level Dependence (BOLD), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1\&T2-mapping imaging and Magnetic Resonance Elastography (MRE). In addition to the imaging, these participants will have their blood creatinine, cystatin C, and blood pressure measured within 3 days before and after the MRE. A renal biopsy will be performed as part of their clinical assessment to evaluate the extent of kidney damage.

Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

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.

Healthy Volunteers

Age-matched healthy individuals with no known kidney disease will be recruited. They will undergo the same MRI protocols as the Diabetics group, including Blood Oxygen Level Dependence (BOLD), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1\&T2-mapping imaging and Magnetic Resonance Elastography (MRE), to establish baseline viscoelasticity parameters for comparison with the Diabetics.

Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes