Prognostic Imaging Biomarkers for Diabetic Kidney Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

MRI (magnetic resonance imaging): An 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): An ultrasound scan is a medical test that uses high-frequency sound waves to capture live images from the inside of the body.

Renal Biopsy: A 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): Positron 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: Glycocalyx (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.

Study summary

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

Primary outcome measure(s)

• Cross-sectional (multi-centre collaboration) — 2 years
  MRI biomarkers will be combined with fluid-based biomarkers to discover radiomics features that correlate with renal function

Trial sites (7)

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