Identifying imaging biomarkers for diabetic kidney disease

Prognostic Imaging Biomarkers for Diabetic Kidney Disease

This study is trying to find new ways to use MRI and ultrasound images to better understand and predict kidney problems in people with diabetes.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Leeds (Academic / other)
• Locations: 7 sites (Turku and 6 other locations)
• Trial ID: NCT03716401 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with Type 2 diabetes and an eGFR of 30 ml/min/1.73m2 or higher.

Not a fit: Patients with significant comorbidities, those on permanent dialysis, or with a life expectancy of less than one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved identification of patients at high risk for diabetic kidney disease, enabling timely interventions.

How similar studies have performed: Other studies have shown promise in using imaging biomarkers for kidney disease, suggesting a potential for success in this approach.

Eligibility criteria

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 this trial is running

Turku and 6 other locations

• Turun Yliopisto — Turku, Finland (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)
• University of Exeter — Exeter, United Kingdom (Not_yet_recruiting)
• University of Leeds — Leeds, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Steven Sourbron, PhD

Conditions Diabetic Kidney Disease; Magnetic Resonance Imaging; Ultrasound Imaging; Biomarkers; Prognosis