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

Gooding, Kim ; Maziarz, Marlena LU ; Dutius Andersson, Anna-Maria LU ; Zetterqvist, Anna LU orcid ; Gomez, Maria F LU orcid and Sourbron, Steven (2020) In BMC Nephrology 21(1).
Abstract
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... (More)
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 ). (Less)
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type
Contribution to journal
publication status
published
subject
keywords
Albuminuria, Biomarkers, Chronic kidney disease stages 1–3, Diabetic kidney disease, Magnetic resonance imaging, Progression, Prospective cohort, Renal decline, Type 2 diabetes, Ultrasound
in
BMC Nephrology
volume
21
issue
1
article number
242
publisher
BioMed Central (BMC)
external identifiers
  • pmid:32600374
  • scopus:85087394148
ISSN
1471-2369
DOI
10.1186/s12882-020-01901-x
language
English
LU publication?
yes
additional info
Export Date: 16 July 2020
id
a3ce7b3e-d8ed-46db-8513-ff6aff2d6aed
date added to LUP
2020-07-16 10:59:19
date last changed
2022-04-18 23:31:07
@article{a3ce7b3e-d8ed-46db-8513-ff6aff2d6aed,
  abstract     = {{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 ).}},
  author       = {{Gooding, Kim and Maziarz, Marlena and Dutius Andersson, Anna-Maria and Zetterqvist, Anna and Gomez, Maria F and Sourbron, Steven}},
  issn         = {{1471-2369}},
  keywords     = {{Albuminuria; Biomarkers; Chronic kidney disease stages 1–3; Diabetic kidney disease; Magnetic resonance imaging; Progression; Prospective cohort; Renal decline; Type 2 diabetes; Ultrasound}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{BMC Nephrology}},
  title        = {{Prognostic imaging biomarkers for diabetic kidney disease (iBEAt): study protocol}},
  url          = {{http://dx.doi.org/10.1186/s12882-020-01901-x}},
  doi          = {{10.1186/s12882-020-01901-x}},
  volume       = {{21}},
  year         = {{2020}},
}