Prognostic Imaging Biomarkers for Diabetic Kidney Disease
iBEAt
1 other identifier
observational
500
6 countries
7
Brief Summary
Diabetic kidney disease (DKD) is a common complication of diabetes, and is now the most common form of chronic kidney disease. DKD is the leading cause of kidney disease requiring dialysis or kidney transplantation, and its global incidence and prevalence have reached epidemic levels. While the risk of developing DKD can be ameliorated by tight blood glucose and blood pressure control, it is not fully preventable and once established DKD cannot be cured. Therefore many patients are left with poor and worsening health and with increased mortality risk. Developing new ways to treat DKD requires healthcare professionals to be able to identify those patients most in need of treatment. One promising approach for identifying patients that are at risk is the use of imaging measurements (called "biomarkers") derived from Magnetic Resonance Imaging (MRI) and Ultrasound (US) of the kidneys. Evidence from early studies shows that such imaging biomarkers can identify underlying problems in DKD such as blood supply, oxygen supply, kidney scarring and kidney function, in ways that are better than those currently available. The investigators think that imaging biomarkers will improve the identification of patients who are likely to decline from DKD in the short term. The changes found by imaging may even happen before effects on the blood and urine. The investigators plan to test this hypothesis by performing a study observing 500 patients with early stage DKD, recruited in 5 sites across Europe. All patients will have detailed assessment at the start of their involvement, including clinical assessment, blood and urine samples, and MRI and US scans. The investigators will look at whether imaging biomarkers are associated with other measures that predict progression in DKD, and follow patients every year for 3 years (4 years total study participation) to see if the imaging biomarkers predict worsening DKD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2038
ExpectedJanuary 11, 2021
January 1, 2021
4 years
March 1, 2018
January 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cross-sectional (multi-centre collaboration)
MRI biomarkers will be combined with fluid-based biomarkers to discover radiomics features that correlate with renal function
2 years
Secondary Outcomes (1)
Longitudinal (multi-centre collaboration)
4 years
Other Outcomes (5)
Turku PET Cohort - Renal Blood Flow
2 years
Bari Biopsy Cohort - Total number of glomeruli
2 years
Leeds Microstructure MRI Cohort - Novel biomarkers of renal microstructure
2 years
- +2 more other outcomes
Study Arms (5)
Bari: Biopsy Arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples. Additionally, participants at the Bari site will have an additional renal biopsy at baseline.
Bordeaux: MRI Follow-up arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples. Additionally, participants at the Bordeaux site will have an additional ultrasound US and MRI in Follow-up year 2.
Exeter: Microvascular arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples. Participants at the Exeter site will undergo microvascular measurements including estimating glycocalyx thickness at baseline and at 2 years follow-up.
Leeds: Microstructure MRI arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. Participants at the Leeds' site will have an extended MRI scan at baseline including novel microstructure MRI measurements.
Turku: PET arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples. Additionally, participants at the Turku site will undergo a renal Positron Emission Tomography (PET) scan at the baseline timepoint.
Interventions
An MRI (or magnetic resonance imaging) scan is a radiology technique that uses magnetism, radio waves, and a computer to produce images of body structures. The MRI scanner is a tube surrounded by a circular magnet.
An ultrasound scan is a medical test that uses high-frequency sound waves to capture live images from the inside of the body.
A kidney biopsy involves taking one or more tiny pieces (samples) of the kidney to look at with special microscopes. The microscopes make it possible to see the samples in greater detail.
Positron emission tomography (PET) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions. By identifying body changes at the cellular level, PET may detect the early onset of disease before it is evident on other imaging tests.
Glycocalyx (a network of membrane proteoglycans and glycoproteins lining all blood vessels) thickness is non-invasively estimated from video clips of sublingual vessels captured using a hand held microscope. Glycocalyx is vital for vascular health; perturbations in the glycocalyx are thought to contribute to numerous vascular health complications including DKD.
Eligibility Criteria
It is the goal of this study to be as inclusive of Type 2 Diabetes as possible, to create a heterogeneous population of participants in the effort to subcategorize to the greatest extent possible for cross-sectional analysis and potential biomarker identification.
You may qualify if:
- 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).
You may not qualify if:
- 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);
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- University of Exetercollaborator
- University Hospital, Bordeauxcollaborator
- University of Baricollaborator
- University of Turkucollaborator
- Lund Universitycollaborator
- Swiss Institute of Bioinformaticscollaborator
Study Sites (7)
Turun Yliopisto
Turku, Finland
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
UniversitĂ degli Studi di Bari Aldo Moro
Bari, Apulia, Italy
Lund University Diabetes Centre
Malmo, 214 28, Sweden
Swiss Institute of Bioinformatics
Lausanne, 1015, Switzerland
University of Exeter
Exeter, United Kingdom
University of Leeds
Leeds, United Kingdom
Related Publications (2)
Grenier N, Merville P, Combe C. Radiologic imaging of the renal parenchyma structure and function. Nat Rev Nephrol. 2016 Jun;12(6):348-59. doi: 10.1038/nrneph.2016.44. Epub 2016 Apr 12.
PMID: 27067530BACKGROUNDGooding KM, Lienczewski C, Papale M, Koivuviita N, Maziarz M, Dutius Andersson AM, Sharma K, Pontrelli P, Garcia Hernandez A, Bailey J, Tobin K, Saunavaara V, Zetterqvist A, Shelley D, Teh I, Ball C, Puppala S, Ibberson M, Karihaloo A, Metsarinne K, Banks RE, Gilmour PS, Mansfield M, Gilchrist M, de Zeeuw D, Heerspink HJL, Nuutila P, Kretzler M, Welberry Smith M, Gesualdo L, Andress D, Grenier N, Shore AC, Gomez MF, Sourbron S; BEAt-DKD consortium. Prognostic imaging biomarkers for diabetic kidney disease (iBEAt): study protocol. BMC Nephrol. 2020 Jun 29;21(1):242. doi: 10.1186/s12882-020-01901-x.
PMID: 32600374DERIVED
Related Links
Biospecimen
Blood and urine samples will be collected from all study participants, including serum, plasma, DNA, and RNA samples. A first morning and additional urine void are requested by all participants
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steven sourbron
University of Leeds
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
March 1, 2018
First Posted
October 23, 2018
Study Start
September 1, 2018
Primary Completion
September 1, 2022
Study Completion (Estimated)
September 1, 2038
Last Updated
January 11, 2021
Record last verified: 2021-01