Prognostic Imaging Biomarkers for Diabetic Kidney Disease
ConditionDiabetic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Leeds
About this trial
Diabetic kidney disease (DKD) is a common complication of diabetes, and is now the most common form of chronic kidney disease. DKD is the leading cause of kidney disease requiring dialysis or kidney transplantation, and its global incidence and prevalence have reached epidemic levels. While the risk of developing DKD can be ameliorated by tight blood glucose and blood pressure control, it is not fully preventable and once established DKD cannot be cured. Therefore many patients are left with poor and worsening health and with increased mortality risk. Developing new ways to treat DKD requires healthcare professionals to be able to identify those patients most in need of treatment.
One promising approach for identifying patients that are at risk is the use of imaging measurements (called "biomarkers") derived from Magnetic Resonance Imaging (MRI) and Ultrasound (US) of the kidneys. Evidence from early studies shows that such imaging biomarkers can identify underlying problems in DKD such as blood supply, oxygen supply, kidney scarring and kidney function, in ways that are better than those currently available.
The investigators think that imaging biomarkers will improve the identification of patients who are likely to decline from DKD in the short term. The changes found by imaging may even happen before effects on the blood and urine.
The investigators plan to test this hypothesis by performing a study observing 500 patients with early stage DKD, recruited in 5 sites across Europe. All patients will have detailed assessment at the start of their involvement, including clinical assessment, blood and urine samples, and MRI and US scans. The investigators will look at whether imaging biomarkers are associated with other measures that predict progression in DKD, and follow patients every year for 3 years (4 years total study participation) to see if the imaging biomarkers predict worsening DKD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis Diabetes Type 2;
eGFR >= 30 ml/min/1.73m2;
Able to provide informed consent;
Age between 18 years and 80 years;
Disqualifiers
Transplantation (except corneal);
On permanent dialysis;
Significant comorbidities with life expectancy of < 1 year;
Use of investigational drug within 1 month prior to screening;
Trial population
It is the goal of this study to be as inclusive of Type 2 Diabetes as possible, to create a heterogeneous population of participants in the effort to subcategorize to the greatest extent possible for cross-sectional analysis and potential biomarker identification.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
MRI (magnetic resonance imaging)
Diagnostic testAn MRI (or magnetic resonance imaging) scan is a radiology technique that uses magnetism, radio waves, and a computer to produce images of body structures. The MRI scanner is a tube surrounded by a circular magnet.
US (ultrasound)
Diagnostic testAn ultrasound scan is a medical test that uses high-frequency sound waves to capture live images from the inside of the body.
Renal Biopsy
Procedure/SurgeryA kidney biopsy involves taking one or more tiny pieces (samples) of the kidney to look at with special microscopes. The microscopes make it possible to see the samples in greater detail.
Positron Emission Tomography (PET)
Diagnostic testPositron emission tomography (PET) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions. By identifying body changes at the cellular level, PET may detect the early onset of disease before it is evident on other imaging tests.
Microvascular Assessment
Diagnostic testGlycocalyx (a network of membrane proteoglycans and glycoproteins lining all blood vessels) thickness is non-invasively estimated from video clips of sublingual vessels captured using a hand held microscope. Glycocalyx is vital for vascular health; perturbations in the glycocalyx are thought to contribute to numerous vascular health complications including DKD.
Treatment groups
500 Participants
are divided into 5 treatment groupsGroup A: Bari: Biopsy Arm3 interventions
Group B: Bordeaux: MRI Follow-up arm2 interventions
Group C: Exeter: Microvascular arm3 interventions
Group D: Leeds: Microstructure MRI arm2 interventions
Group E: Turku: PET arm3 interventions
Trial outcomes
Primary outcomes
1
Cross-sectional (multi-centre collaboration)
MRI biomarkers will be combined with fluid-based biomarkers to discover radiomics features that correlate with renal function
Time frame
2 yearsSecondary outcomes
1
Longitudinal (multi-centre collaboration)
MRI biomarkers will be combined with patient follow-up data to discover radiomics features that correlate with disease progression
Time frame
4 yearsOther outcomes
1
Turku PET Cohort - Renal Blood Flow
Renal Blood Flow measured by Water-labelled PET/MRI
Time frame
2 years2
Bari Biopsy Cohort - Total number of glomeruli
Total number of glomeruli measured on renal histopathology
Time frame
2 years3
Leeds Microstructure MRI Cohort - Novel biomarkers of renal microstructure
Novel biomarkers of renal microstructure measured with Diffusion Tensor Imaging and 3D Dynamic Contrast-Enhanced MRI
Time frame
2 years4
Bordeaux MRI Follow-up Cohort - two-year rate of change in MRI biomarkers and radiomic signatures
Two-year rate of change in MRI biomarkers and radiomic signatures
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leeds
Lead sponsor
University of Exeter
Collaborator
University Hospital, Bordeaux
Collaborator
University of Bari
Collaborator
University of Turku
Collaborator
Lund University
Collaborator
Swiss Institute of Bioinformatics
Collaborator
Source ClinicalTrials.gov