Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease
ConditionDiabetic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShengjing Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinically diagnosed diabetic kidney disease (DKD)
Age 18-80 years
Disqualifiers
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
Trial population
Study subject inclusion criteria were adult patients with clinically diagnosed diabetic kidney disease (DKD), without evidence of non-diabetic kidney injury.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Magnetic Resonance Imaging
Diagnostic testBoth 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: DKD Patients1 intervention
Group B: Healthy Volunteers1 intervention
Trial outcomes
Primary outcomes
1
Rate of Decline in Estimated Glomerular Filtration Rate (eGFR Slope)
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.
Time frame
From enrollment to the end of follow-up at 24 monthsSponsors and contacts
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Source ClinicalTrials.gov