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

被引：27

作者：

Gooding, Kim M. ^{[1
,2
]}

Lienczewski, Chrysta ^{[3
]}

Papale, Massimo ^{[4
]}

Koivuviita, Niina ^{[5
,6
]}

Maziarz, Marlena ^{[7
]}

Dutius Andersson, Anna-Maria ^{[7
]}

Sharma, Kanishka ^{[8
]}

Pontrelli, Paola ^{[4
]}

Garcia Hernandez, Alberto ^{[9
]}

Bailey, Julie ^{[10
]}

Tobin, Kay ^{[11
]}

Saunavaara, Virva ^{[12
]}

Zetterqvist, Anna ^{[7
]}

Shelley, David ^{[10
,13
]}

Teh, Irvin ^{[14
]}

Ball, Claire ^{[2
]}

Puppala, Sapna ^{[10
]}

Ibberson, Mark ^{[15
]}

Karihaloo, Anil ^{[16
]}

Metsarinne, Kaj ^{[5
]}

Banks, Rosamonde E. ^{[17
]}

Gilmour, Peter S. ^{[18
]}

Mansfield, Michael ^{[10
]}

Gilchrist, Mark ^{[1
]}

de Zeeuw, Dick ^{[19
,20
]}

Heerspink, Hiddo J. L. ^{[19
,20
]}

Nuutila, Pirjo ^{[5
,6
]}

Kretzler, Matthias ^{[3
,21
]}

Welberry Smith, Matthew ^{[11
]}

Gesualdo, Loreto ^{[4
]}

Andress, Dennis ^{[22
]}

Grenier, Nicolas ^{[23
]}

Shore, Angela C. ^{[1
,2
]}

Gomez, Maria F. ^{[7
]}

Sourbron, Steven ^{[8
]}

机构：

[1] Univ Exeter, Med Sch, Diabet & Vasc Med, Barrack Rd, Exeter EX2 5AX, Devon, England

[2] Royal Devon & Exeter NHS Fdn Trust, NIHR Exeter Clin Res Facil, Exeter, Devon, England

[3] Univ Michigan, Dept Nephrol, Ann Arbor, MI 48109 USA

[4] Univ Bari Aldo Moro, Nephrol Unit, Dept Emergency & Organ Transplantat, Bari, Italy

[5] Turku Univ Hosp, Div Nephrol, Dept Med, Turku, Finland

[6] Univ Turku, Turku PET Ctr, Turku, Finland

[7] Lund Univ, Diabet Ctr, Dept Clin Sci Malmo, Malmo, Sweden

[8] Univ Sheffield, Dept Imaging Infect Immun & Cardiovasc Dis, Sheffield, S Yorkshire, England

[9] Astellas Pharma Europe BV, Meppel, Netherlands

[10] Leeds Teaching Hosp NHS Trust, Leeds, W Yorkshire, England

[11] Leeds Teaching Hosp NHS Trust, Dept Renal Med & Renal Transplantat, Leeds, W Yorkshire, England

[12] Turku Univ Hosp, Div Med Imaging, Dept Med Phys, Turku, Finland

[13] Univ Leeds, Adv Imaging Ctr, Leeds, W Yorkshire, England

[14] Univ Leeds, Leeds Inst Cardiovasc & Metab Med, Leeds, W Yorkshire, England

[15] Swiss Inst Bioinformat, Lausanne, Switzerland

[16] Novo Nordisk Res Ctr Seattle Inc, Seattle, WA USA

[17] Univ Leeds, Leeds Inst Med Res St Jamess, Leeds, W Yorkshire, England

[18] Drug Dev Team, Leiden, Netherlands

[19] Univ Med Ctr Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands

[20] Univ Groningen, Groningen, Netherlands

[21] Univ Michigan, Computat Med & Bioinformat, Ann Arbor, MI USA

[22] AbbVie, Scottsdale, AZ USA

[23] Univ Bordeaux, CHU Bordeaux, Serv Radiol, Bordeaux, France

来源：

BMC NEPHROLOGY | 2020年 / 21卷 / 01期

基金：

瑞典研究理事会; 英国医学研究理事会;

关键词：

Diabetic kidney disease; Type; 2; diabetes; Magnetic resonance imaging; Ultrasound; Albuminuria; Chronic kidney disease stages 1-3; Prospective cohort; Renal decline; Biomarkers; Progression; RENAL-FUNCTION; DIFFUSION; MRI; POPULATION; SELECTION; DECLINE;

D O I：

10.1186/s12882-020-01901-x

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

1002 ; 100201 ;

摘要：

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(2). 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 H(2)O(15)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.

引用

页数：11

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