Identifying imaging biomarkers for diabetic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify prognostic imaging biomarkers for diabetic kidney disease (DKD) using Magnetic Resonance Imaging (MRI) and Ultrasound (US). Conducted across six European countries, it will involve a cross-sectional phase to establish associations and a longitudinal phase for prognostic evaluation. Participants will undergo standardized assessments, including demographic data, clinical history, and imaging procedures, with annual follow-ups for additional data collection. The study will also centralize biofluid samples for future biomarker validation.

Why it matters

Who can join: the full rules

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;

Where it's running

• Turun Yliopisto
  Turku, Finland Recruiting
• University of Leeds
  Leeds, United Kingdom Recruiting
• Centre Hospitalier Universitaire de Bordeaux
  Bordeaux, France Not yet recruiting
• Università degli Studi di Bari Aldo Moro
  Bari, Apulia, Italy Not yet recruiting
• Lund University Diabetes Centre
  Malmö, Sweden Active not recruiting
• Swiss Institute of Bioinformatics
  Lausanne, Switzerland Active not recruiting

Study contacts

• Study coordinator: Steven Sourbron, PhD
• Email: s.sourbron@leeds.ac.uk
• Phone: 0044-113-34-38003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.