Clinical trial NCT06452862: Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease
Official title: the Value of Multimodal Magnetic Resonance Imaging in the Diagnosis and Treatment Monitoring of Diabetic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Kidney Disease
Keywords: Diabetic Kidney Disease
Magnetic Resonance Imaging
Magnetic Resonance Elastography
Diabetes
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study subject inclusion criteria were adult patients with diabetes without non-diabetic kidney injury.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Imaging Evaluation of Kidney
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Yu Shi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.