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Prognostic Imaging Biomarkers for Diabetic Kidney Disease

Recruitingn/aAges 18 Years - 80 YearsAllUniversity of Leeds
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In plain words

What the trial is, and whether it could suit you

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. Evide

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Transplantation (except corneal); * On permanent dialysis; * Significant comorbidities with life expectancy of \< 1 year; * Use of investigational drug within 1 month prior to screening; * 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; * Current pregnancy; * History of Hepatitis B or Hepatitis C +; * Use of antiretroviral medication; * Known current or clinical history of renal or urinary tract malignancy; * Concurrent other renal disease (suspected or proven); * Cirrhotic liver disease, or non-cirrhotic chronic liver disease where ALT \>2 x upper limit of normal; * Current metastatic malignancy; * Current malignancy with expected survival \< study follow up period (4 years); * Melanomatous skin cancer \< 5 years ago (fully resected melanoma \>5 years ago, i.e. surgical cure, can be recruited); * 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; * Cochlear Implant; * Aneurysm Clips; * Neurological stimulator; * Implanted cardiac devices (ICD, PPM, loop recorders, or any others); * Metal heart valve; * History of metal foreign bodies in orbits; * Other implanted metal device which prevents MR imaging; * Known allergy to Gadolinium contrast; * Claustrophobia; * Weight exceeding 250 kg; * \[Bari arm\] Absolute contraindications to percutaneous renal biopsy; * \[Bari arm\] Bleeding diathesis; * \[Bari arm\] Severe uncontrolled hypertension; * \[Bari arm\] End stage renal disease with small hyperechoic kidneys;
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What it tests

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

7 sites
Turun Yliopisto
Turku, Finland
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Università degli Studi di Bari Aldo Moro
Bari, Italy
Lund University Diabetes Centre
Malmö, Sweden
Swiss Institute of Bioinformatics
Lausanne, Switzerland
University of Exeter
Exeter, United Kingdom
University of Leeds
Leeds, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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