Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease

NCT06452862 | Recruiting

• 1 other identifier: ShengjingH-DKD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Kidney Disease

Keywords

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

Outcome Measures

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.

  From enrollment to the end of follow-up at 24 months

Study Arms (2)

DKD Patients

Participants with diagnosed Diabetic Kidney Disease (DKD) 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, blood pressure, and urine albumin-to-creatinine ratio (UACR) measured within 3 days before and after the MRE. A renal biopsy will be performed in a subset of these participants as part of their clinical assessment to evaluate the extent of kidney damage.

Diagnostic Test: Magnetic Resonance Imaging

Healthy Volunteers

Age-matched healthy individuals with no known kidney disease will be recruited. They will undergo the same MRI protocols as the DKD 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.

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

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.

DKD Patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study subject inclusion criteria were adult patients with clinically diagnosed diabetic kidney disease (DKD), without evidence of non-diabetic kidney injury.

You may qualify if:

• Clinically diagnosed diabetic kidney disease (DKD)
• Age 18-80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

RECRUITING

Related 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.

  PMID: 31329940 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yu Shi, M.D.

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Shi, M.D.

CONTACT

18940259980; 18940259980@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of department of radiology

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): June 6, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)