Imaging Scans to Predict Kidney Decline in Diabetic Kidney Disease
Studies whether kidney MRI and ultrasound scans can predict worsening in early diabetic kidney disease.
Plain-language title generated from the registry record
Registry title: Prognostic Imaging Biomarkers for Diabetic Kidney Disease
Key facts
- Where
- Lausanne, SwitzerlandSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT03716401, who can take part
Where in Switzerland
- Swiss Institute of BioinformaticsLausanne, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Leeds
- Trial code
- NCT03716401
- Record updated
- 11 January 2021
- Original description
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.Read full original descriptionShow less
Prognostic Imaging Biomarkers for Diabetic Kidney Disease
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.
Inclusion: Diagnosis Diabetes Type 2; eGFR >= 30 ml/min/1.73m2; Able to provide informed consent; Age between 18 years and 80 years; Unchanged antidiabetic and antihypertensive medication for the past 3 months (not including dose changes).
Exclusion: Transplantation (except corneal); Use of investigational drug within 1 month prior to screening; Use of antiretroviral medication; Concurrent other renal disease (suspected or proven); Cochlear Implant; Known clinical history of urinary obstruction on renal US: either post-voiding residue over 100 ml, or pyelectasis; Known clinical history of aortic endoprosthesis at the renal level; History of Hepatitis B or Hepatitis C +; Known current or clinical history of renal or urinary tract malignancy; Current metastatic malignancy; Current malignancy with expected survival < study follow up period (4 years); Any other significant disease or disorder which, in the opinion of the investigators, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study; Implanted cardiac devices (ICD, PPM, loop recorders, or any others); Metal heart valve; History of metal foreign bodies in orbits; Known allergy to Gadolinium contrast; [Bari arm] Bleeding diathesis; [Bari arm] Severe uncontrolled hypertension; [Bari arm] End stage renal disease with small hyperechoic kidneys; Cirrhotic liver disease, or non-cirrhotic chronic liver disease where ALT >2 x upper limit of normal; Melanomatous skin cancer < 5 years ago (fully resected melanoma >5 years ago, i.e. surgical cure, can be recruited); On permanent dialysis; Significant comorbidities with life expectancy of < 1 year; Current pregnancy; Aneurysm Clips; Neurological stimulator; Other implanted metal device which prevents MR imaging; Claustrophobia; Weight exceeding 250 kg; [Bari arm] Absolute contraindications to percutaneous renal biopsy.