Prognostic Imaging Biomarkers for Diabetic 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

Qualifiers

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 design

Treatments tested in this trial

  • MRI (magnetic resonance imaging)
  • US (ultrasound)
  • Renal Biopsy
  • Positron Emission Tomography (PET)
  • Microvascular Assessment

Treatment groups

500 Participants
are divided into 5 treatment groups

Sponsors and collaborators

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