[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100340735":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":64,"centralContacts":68,"locations":78,"responsibleParty":181,"collaborators":184,"id":196,"slug":197,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":198,"sex":203,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":10,"studyType":209,"phases":10,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":81,"whyStopped":10,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"University of Leeds","OTHER",[8,16,20,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Bari: Biopsy Arm",null,"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.\n\nAdditionally, participants at the Bari site will have an additional renal biopsy at baseline.",[13,14,15],"Diagnostic Test: MRI (magnetic resonance imaging)","Diagnostic Test: US (ultrasound)","Procedure: Renal Biopsy",{"label":17,"type":10,"description":18,"interventionNames":19},"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.\n\nAdditionally, participants at the Bordeaux site will have an additional ultrasound US and MRI in Follow-up year 2.",[13,14],{"label":21,"type":10,"description":22,"interventionNames":23},"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.\n\nParticipants at the Exeter site will undergo microvascular measurements including estimating glycocalyx thickness at baseline and at 2 years follow-up.",[13,14,24],"Diagnostic Test: Microvascular Assessment",{"label":26,"type":10,"description":27,"interventionNames":28},"Leeds: Microstructure MRI arm","All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection.\n\nParticipants at the Leeds' site will have an extended MRI scan at baseline including novel microstructure MRI measurements.",[13,14],{"label":30,"type":10,"description":31,"interventionNames":32},"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.\n\nAdditionally, participants at the Turku site will undergo a renal Positron Emission Tomography (PET) scan at the baseline timepoint.",[13,14,33],"Diagnostic Test: Positron Emission Tomography (PET)",[35,40,46,54,60],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"DIAGNOSTIC_TEST","MRI (magnetic resonance imaging)","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.",[9,17,21,26,30],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"US (ultrasound)","An ultrasound scan is a medical test that uses high-frequency sound waves to capture live images from the inside of the body.",[9,17,21,26,30],[45],"Sonography",{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"PROCEDURE","Renal Biopsy","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.",[9],[52,53],"Kidney biopsy","percutaneous renal biopsy",{"type":36,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Positron Emission Tomography (PET)","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.",[30],[59],"PET scan",{"type":36,"name":61,"description":62,"armGroupLabels":63,"otherNames":10},"Microvascular Assessment","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.",[21],[65],{"name":66,"affiliation":5,"role":67},"Steven sourbron","STUDY_CHAIR",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":10,"email":73},"Steven Sourbron, PhD","CONTACT","0044-113-34-38003","s.sourbron@leeds.ac.uk",{"name":75,"role":71,"phone":76,"phoneExt":10,"email":77},"Chrysta C Lienczewski, BS","734-615-5021","boridley@umich.edu",[79,98,115,132,144,155,171],{"facility":80,"status":81,"city":82,"state":10,"zip":10,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Turun Yliopisto","RECRUITING","Turku","Finland","FI",{"type":86,"coordinates":87},"Point",[88,89],22.26869,60.45148,{"lat":89,"lon":88},[92,95],{"name":93,"role":71,"phone":10,"phoneExt":10,"email":94},"Niina Koivuviita, MD","niina.koivuviita@tyks.fi",{"name":96,"role":97,"phone":10,"phoneExt":10,"email":10},"Pirjo Nuutila, MD","PRINCIPAL_INVESTIGATOR",{"facility":99,"status":100,"city":101,"state":10,"zip":10,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Centre Hospitalier Universitaire de Bordeaux","NOT_YET_RECRUITING","Bordeaux","France","FR",{"type":86,"coordinates":105},[106,107],-0.58046,44.84124,{"lat":107,"lon":106},[110,113],{"name":111,"role":71,"phone":10,"phoneExt":10,"email":112},"Corinne Castermans","corinne.castermans@chu-bordeaux.fr",{"name":114,"role":97,"phone":10,"phoneExt":10,"email":10},"Nicolas Grenier, MD",{"facility":116,"status":100,"city":117,"state":118,"zip":10,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Università degli Studi di Bari Aldo Moro","Bari","Apulia","Italy","IT",{"type":86,"coordinates":122},[123,124],16.86982,41.12066,{"lat":124,"lon":123},[127,130],{"name":128,"role":71,"phone":10,"phoneExt":10,"email":129},"Massimo Papale, PhD","mpapale78@gmail.com",{"name":131,"role":97,"phone":10,"phoneExt":10,"email":10},"Loreto Gesualdo, MD",{"facility":133,"status":134,"city":135,"state":10,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":10},"Lund University Diabetes Centre","ACTIVE_NOT_RECRUITING","Malmö","214 28","Sweden","SE",{"type":86,"coordinates":140},[141,142],13.00073,55.60587,{"lat":142,"lon":141},{"facility":145,"status":134,"city":146,"state":10,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":10},"Swiss Institute of Bioinformatics","Lausanne","1015","Switzerland","CH",{"type":86,"coordinates":151},[152,153],6.63282,46.516,{"lat":153,"lon":152},{"facility":156,"status":100,"city":157,"state":10,"zip":10,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"University of Exeter","Exeter","United Kingdom","UK",{"type":86,"coordinates":161},[162,163],-3.52751,50.7236,{"lat":163,"lon":162},[166,169],{"name":167,"role":71,"phone":10,"phoneExt":10,"email":168},"Kim Gooding, PhD","k.m.gooding@exeter.ac.uk",{"name":170,"role":97,"phone":10,"phoneExt":10,"email":10},"Angela Shore, PhD",{"facility":5,"status":81,"city":172,"state":10,"zip":10,"country":158,"countryCode":159,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Leeds",{"type":86,"coordinates":174},[175,176],-1.54785,53.79648,{"lat":176,"lon":175},[179,180],{"name":70,"role":71,"phone":10,"phoneExt":10,"email":73},{"name":70,"role":97,"phone":10,"phoneExt":10,"email":10},{"type":97,"investigatorFullName":182,"investigatorTitle":183,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Steven Sourbron","Lecturer",[185,186,188,190,192,194],{"name":156,"class":6},{"name":187,"class":6},"University Hospital, Bordeaux",{"name":189,"class":6},"University of Bari",{"name":191,"class":6},"University of Turku",{"name":193,"class":6},"Lund University",{"name":145,"class":195},"UNKNOWN","100340735","prognostic-imaging-biomarkers-for-diabetic-kidney-disease-100340735",false,"NCT03716401","Prognostic Imaging Biomarkers for Diabetic Kidney Disease","iBEAt","Inclusion Criteria:\n\n* Diagnosis Diabetes Type 2;\n* eGFR \\>= 30 ml\u002Fmin\u002F1.73m2;\n* Able to provide informed consent;\n* Age between 18 years and 80 years;\n* Unchanged antidiabetic and antihypertensive medication for the past 3 months (not including dose changes).\n\nExclusion Criteria:\n\n* Transplantation (except corneal);\n* On permanent dialysis;\n* Significant comorbidities with life expectancy of \\\u003C 1 year;\n* Use of investigational drug within 1 month prior to screening;\n* Known clinical history of urinary obstruction on renal US: either post-voiding residue over 100 ml, or pyelectasis;\n* Known clinical history of aortic endoprosthesis at the renal level;\n* Current pregnancy;\n* History of Hepatitis B or Hepatitis C +;\n* Use of antiretroviral medication;\n* Known current or clinical history of renal or urinary tract malignancy;\n* Concurrent other renal disease (suspected or proven);\n* Cirrhotic liver disease, or non-cirrhotic chronic liver disease where ALT \\>2 x upper limit of normal;\n* Current metastatic malignancy;\n* Current malignancy with expected survival \\\u003C study follow up period (4 years);\n* Melanomatous skin cancer \\\u003C 5 years ago (fully resected melanoma \\>5 years ago, i.e. surgical cure, can be recruited);\n* Any other significant disease or disorder which, in the opinion of the investigators, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study;\n* Cochlear Implant;\n* Aneurysm Clips;\n* Neurological stimulator;\n* Implanted cardiac devices (ICD, PPM, loop recorders, or any others);\n* Metal heart valve;\n* History of metal foreign bodies in orbits;\n* Other implanted metal device which prevents MR imaging;\n* Known allergy to Gadolinium contrast;\n* Claustrophobia;\n* Weight exceeding 250 kg;\n* \\[Bari arm\\] Absolute contraindications to percutaneous renal biopsy;\n* \\[Bari arm\\] Bleeding diathesis;\n* \\[Bari arm\\] Severe uncontrolled hypertension;\n* \\[Bari arm\\] End stage renal disease with small hyperechoic kidneys;","ALL","18 Years","80 Years",{"count":207,"type":208},500,"ESTIMATED","OBSERVATIONAL","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.\n\nOne 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.\n\nThe 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.\n\nThe 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.",[212],"Diabetic Kidney Disease",[214,215,216,217],"Magnetic Resonance Imaging","Ultrasound Imaging","Biomarkers","Prognosis","2021-01-08",{"date":220,"type":221},"2021-01-11","ACTUAL",{"date":223,"type":221},"2018-09-01",{"date":225,"type":208},"2038-09-01",{"name":5,"class":6},7]