Prognostic imaging biomarkers for diabetic kidney disease (iBEAt): study protocol

Autor: Dick de Zeeuw, M.W. Mansfield, Matthew Wellberry-Smith, Nicolas Grenier, Anna V. Zetterqvist, Anna-Maria Dutius Andersson, Kim M. Gooding, Loreto Gesualdo, Massimo Papale, Irvin Teh, Hiddo J.L. Heerspink, Chrysta Lienczewski, Peter S. Gilmour, Sapna Puppala, Pirjo Nuutila, Paola Pontrelli, Mark Gilchrist, Claire Ball, Rosamonde E. Banks, David Shelley, Anil Karihaloo, Marlena Maziarz, Alberto Garcia Hernandez, iBEAt investigators, Kay Tobin, Steven Sourbron, Niina Koivuviita, Angela C. Shore, Mark Ibberson, Matthias Kretzler, Dennis L. Andress, Kanishka Sharma, Julie Bailey, Maria F. Gomez, Kaj Metsärinne, Virva Saunavaara
Přispěvatelé: Groningen Kidney Center (GKC), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)
Rok vydání: 2020
Předmět:
SELECTION
Oncology
Nephrology
030232 urology & nephrology
Type 2 diabetes
Renal decline
030204 cardiovascular system & hematology
lcsh:RC870-923
Kidney
Study Protocol
0302 clinical medicine
Oxygen Radioisotopes
Diabetic Nephropathies
Prospective Studies
Prospective cohort study
POPULATION
Ultrasonography
education.field_of_study
Progression
medicine.diagnostic_test
Prognosis
DIFFUSION
3. Good health
Observational Studies as Topic
Disease Progression
Biomarker (medicine)
medicine.symptom
MRI
Cohort study
RENAL-FUNCTION
medicine.medical_specialty
Population
Chronic kidney disease stages 1–3
Renal function
Renal Circulation
03 medical and health sciences
Magnetic resonance imaging
Internal medicine
Ultrasound
medicine
Humans
Albuminuria
Renal Insufficiency
Chronic
Diabetic kidney disease
education
DECLINE
business.industry
Prospective cohort
lcsh:Diseases of the genitourinary system. Urology
medicine.disease
Diabetes Mellitus
Type 1
Diabetes Mellitus
Type 2
Positron-Emission Tomography
Renal blood flow
Chronic kidney disease stages 1-3
business
Biomarkers
Blood sampling
Zdroj: BMC Nephrology
Bmc nephrology, 21(1):242. BMC
BMC Nephrology, Vol 21, Iss 1, Pp 1-11 (2020)
ISSN: 1471-2369
Popis: Background Diabetic kidney disease (DKD) remains one of the leading causes of premature death in diabetes. DKD is classified on albuminuria and reduced kidney function (estimated glomerular filtration rate (eGFR)) but these have modest value for predicting future renal status. There is an unmet need for biomarkers that can be used in clinical settings which also improve prediction of renal decline on top of routinely available data, particularly in the early stages. The iBEAt study of the BEAt-DKD project aims to determine whether renal imaging biomarkers (magnetic resonance imaging (MRI) and ultrasound (US)) provide insight into the pathogenesis and heterogeneity of DKD (primary aim) and whether they have potential as prognostic biomarkers in DKD (secondary aim). Methods iBEAt is a prospective multi-centre observational cohort study recruiting 500 patients with type 2 diabetes (T2D) and eGFR ≥30 ml/min/1.73m2. At baseline, blood and urine will be collected, clinical examinations will be performed, and medical history will be obtained. These assessments will be repeated annually for 3 years. At baseline each participant will also undergo quantitative renal MRI and US with central processing of MRI images. Biological samples will be stored in a central laboratory for biomarker and validation studies, and data in a central data depository. Data analysis will explore the potential associations between imaging biomarkers and renal function, and whether the imaging biomarkers improve the prediction of DKD progression. Ancillary substudies will: (1) validate imaging biomarkers against renal histopathology; (2) validate MRI based renal blood flow measurements against H2O15 positron-emission tomography (PET); (3) validate methods for (semi-)automated processing of renal MRI; (4) examine longitudinal changes in imaging biomarkers; (5) examine whether glycocalyx and microvascular measures are associated with imaging biomarkers and eGFR decline; (6) explore whether the findings in T2D can be extrapolated to type 1 diabetes. Discussion iBEAt is the largest DKD imaging study to date and will provide valuable insights into the progression and heterogeneity of DKD. The results may contribute to a more personalised approach to DKD management in patients with T2D. Trial registration Clinicaltrials.gov (NCT03716401).
Databáze: OpenAIRE
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