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


Journal

BMC nephrology
ISSN: 1471-2369
Titre abrégé: BMC Nephrol
Pays: England
ID NLM: 100967793

Informations de publication

Date de publication:
29 06 2020
Historique:
received: 13 05 2020
accepted: 19 06 2020
entrez: 1 7 2020
pubmed: 1 7 2020
medline: 9 9 2021
Statut: epublish

Résumé

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). iBEAt is a prospective multi-centre observational cohort study recruiting 500 patients with type 2 diabetes (T2D) and eGFR ≥30 ml/min/1.73m 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. Clinicaltrials.gov ( NCT03716401 ).

Sections du résumé

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/1.73m
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 ).

Identifiants

pubmed: 32600374
doi: 10.1186/s12882-020-01901-x
pii: 10.1186/s12882-020-01901-x
pmc: PMC7323369
doi:

Substances chimiques

Oxygen Radioisotopes 0

Banques de données

ClinicalTrials.gov
['NCT03716401']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

242

Subventions

Organisme : Innovative Medicines Initiative
ID : 115974
Pays : International
Organisme : Swedish Heart and Lung Foundation
ID : 20160872
Pays : International
Organisme : Swedish Research Council
ID : 2018-02837; 2009-1039
Pays : International
Organisme : Swedish Foundation for Strategic Research
ID : LUDC-IRC 15-0067
Pays : International
Organisme : UK Medical Research Council
ID : MR/R02264X/1
Pays : International
Organisme : Kidney Research UK
ID : RP55/2012
Pays : International

Références

J Magn Reson Imaging. 2017 Dec;46(6):1810-1817
pubmed: 28383796
Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii4-ii14
pubmed: 30137584
Nephrol Dial Transplant. 2020 Jun 1;35(6):964-970
pubmed: 30418615
Diabetes. 2006 Sep;55(9):2620-5
pubmed: 16936212
Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii1-ii3
pubmed: 30137582
Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2032-2045
pubmed: 28522654
N Engl J Med. 2006 May 18;354(20):2122-30
pubmed: 16707749
Am J Nephrol. 2011;34(5):476-82
pubmed: 22024476
Nat Rev Nephrol. 2016 Jun;12(6):348-59
pubmed: 27067530
Kidney Blood Press Res. 2018;43(1):181-190
pubmed: 29466797
Diabetes Care. 2004 May;27(5):1047-53
pubmed: 15111519
Kidney Int. 2018 Apr;93(4):932-940
pubmed: 29325997
J Ultrasound Med. 2013 Jun;32(6):1033-40
pubmed: 23716525
BMC Nephrol. 2010 Mar 03;11:3
pubmed: 20199663
Cell Metab. 2018 Oct 2;28(4):547-556.e3
pubmed: 30078554
Diabet Med. 2008 Aug;25 Suppl 2:25-9
pubmed: 18717975
Sci Rep. 2016 Jul 21;6:30088
pubmed: 27439482
Nephrol Dial Transplant. 2020 Mar 11;:
pubmed: 32160279
Kidney Int. 2013 Apr;83(4):749-56
pubmed: 23325076
Magn Reson Med. 2018 Jan;79(1):48-61
pubmed: 29083101
Clin J Am Soc Nephrol. 2017 Dec 7;12(12):1984-1990
pubmed: 29054846
Invest Radiol. 2012 Jul;47(7):430-7
pubmed: 22659594
Nat Rev Nephrol. 2014 Feb;10(2):77-87
pubmed: 24296623
J Am Soc Nephrol. 2010 Apr;21(4):556-63
pubmed: 20167701
Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266
pubmed: 11904577
Lancet. 2013 Jul 20;382(9888):260-72
pubmed: 23727169
J Magn Reson Imaging. 2003 Jan;17(1):104-13
pubmed: 12500279
Diab Vasc Dis Res. 2013 Nov;10(6):520-9
pubmed: 24002670

Auteurs

Kim M Gooding (KM)

Diabetes and Vascular Medicine, University of Exeter Medical School, Barrack Road, Exeter, EX2 5AX, UK. K.M.Gooding@exeter.ac.uk.
NIHR Exeter Clinical Research Facility, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK. K.M.Gooding@exeter.ac.uk.

Chrysta Lienczewski (C)

Department of Nephrology, University of Michigan, Ann Arbor, USA.

Massimo Papale (M)

Department of Emergency and Organ Transplantation, Nephrology Unit, University of Bari Aldo Moro, Bari, Italy.

Niina Koivuviita (N)

Department of Medicine, Division of Nephrology, Turku University Hospital, Turku, Finland.
Turku PET Centre, University of Turku, Turku, Finland.

Marlena Maziarz (M)

Department of Clinical Sciences in Malmö, Lund University Diabetes Centre, Lund University, Malmo, Sweden.

Anna-Maria Dutius Andersson (AM)

Department of Clinical Sciences in Malmö, Lund University Diabetes Centre, Lund University, Malmo, Sweden.

Kanishka Sharma (K)

Department of Imaging, Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.

Paola Pontrelli (P)

Department of Emergency and Organ Transplantation, Nephrology Unit, University of Bari Aldo Moro, Bari, Italy.

Alberto Garcia Hernandez (A)

Astellas Pharma Europe B.V, Meppel, The Netherlands.

Julie Bailey (J)

Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Kay Tobin (K)

Department of Renal Medicine and Renal Transplantation, Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Virva Saunavaara (V)

Department of Medical Physics, Division of Medical Imaging, Turku University Hospital, Turku, Finland.

Anna Zetterqvist (A)

Department of Clinical Sciences in Malmö, Lund University Diabetes Centre, Lund University, Malmo, Sweden.

David Shelley (D)

Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Advanced Imaging Centre, University of Leeds, Leeds, UK.

Irvin Teh (I)

Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.

Claire Ball (C)

NIHR Exeter Clinical Research Facility, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.

Sapna Puppala (S)

Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Mark Ibberson (M)

Swiss Institute of Bioinformatics, Lausanne, Switzerland.

Anil Karihaloo (A)

Novo Nordisk Research Center Seattle, Inc., Seattle, USA.

Kaj Metsärinne (K)

Department of Medicine, Division of Nephrology, Turku University Hospital, Turku, Finland.

Rosamonde E Banks (RE)

Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.

Peter S Gilmour (PS)

The Drug Development Team, Leiden, The Netherlands.

Michael Mansfield (M)

Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Mark Gilchrist (M)

Diabetes and Vascular Medicine, University of Exeter Medical School, Barrack Road, Exeter, EX2 5AX, UK.

Dick de Zeeuw (D)

Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.
University of Groningen, Groningen, The Netherlands.

Hiddo J L Heerspink (HJL)

Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.
University of Groningen, Groningen, The Netherlands.

Pirjo Nuutila (P)

Department of Medicine, Division of Nephrology, Turku University Hospital, Turku, Finland.
Turku PET Centre, University of Turku, Turku, Finland.

Matthias Kretzler (M)

Department of Nephrology, University of Michigan, Ann Arbor, USA.
Computational Medicine and Bioinformatics, University of Michigan, Ann Arbour, USA.

Matthew Welberry Smith (M)

Department of Renal Medicine and Renal Transplantation, Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Loreto Gesualdo (L)

Department of Emergency and Organ Transplantation, Nephrology Unit, University of Bari Aldo Moro, Bari, Italy.

Dennis Andress (D)

AbbVie, Scottsdale, USA.

Nicolas Grenier (N)

Service de Radiologie, CHU de Bordeaux, Université de Bordeaux, Bordeaux, France.

Angela C Shore (AC)

Diabetes and Vascular Medicine, University of Exeter Medical School, Barrack Road, Exeter, EX2 5AX, UK.
NIHR Exeter Clinical Research Facility, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.

Maria F Gomez (MF)

Department of Clinical Sciences in Malmö, Lund University Diabetes Centre, Lund University, Malmo, Sweden.

Steven Sourbron (S)

Department of Imaging, Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.

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