[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558752":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":34,"studyPopulation":26,"armGroups":35,"interventions":46,"overallOfficials":56,"centralContacts":61,"locations":69,"responsibleParty":87,"collaborators":26,"id":90,"slug":26,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":26,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Bispebjerg Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":26},[9,13,16,19,22,24],{"measure":10,"description":11,"timeFrame":12},"Coefficient of variation on total blood flow and regional renal perfusion measurements at rest and during isometric muscle exercise, measured by PET\u002FCT with 15-Oxygen labeled water and MRI","No metric unit","Each participant's study day during the span of the study (approximately 5 months)",{"measure":14,"description":15,"timeFrame":12},"Total blood flow at rest and during isometric muscle exercise measured by PET\u002FCT with 15-Oxygen labeled water and MRI","Volume of blood pr unit time, ml\u002Fmin",{"measure":17,"description":18,"timeFrame":12},"Regional renal perfusion at rest and during isometric muscle exercise measured by PET\u002FCT with 15-Oxygen labeled water and MRI","Volume of blood pr unit time pr unit tissue mass, ml\u002Fmin\u002Fg",{"measure":20,"description":21,"timeFrame":12},"Regional renal oxygenation at rest and during isometric muscle exercise using MRI","Percentage, fraction",{"measure":23,"description":21,"timeFrame":12},"Regional renal extraction of oxygen at rest and during isometric muscle exercise using MRI",{"measure":25,"description":11,"timeFrame":12},"Coefficient of variation on regional renal oxygenation and extraction of oxygen measurements at rest and isometric muscle exercise using MRI",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","CROSSOVER","Each participant will undergo intervention, which is PET\u002FCT, and control, which is MRI. Each participant will have both intervention and control performed the same day in randomized order.","BASIC_SCIENCE",{"masking":33,"maskingDescription":26,"whoMasked":26},"NONE","Measuring tissue perfusion with PET\u002FCT using 15-oxygen labeled water is routinely used as a non-invasive tool to examine cerebral and myocardial perfusion. With a 100% tissue extraction, 15-oxygen labeled water is gold standard.\n\nThe aim of the present study is to validate renal perfusion measurements with PET\u002FCT using 15-oxygen labeled water as tracer against the validated multiparametric MRI technique.\n\nOnce validated the imaging technique will be beneficial in examining vascular damage in the kidneys caused by different renal diseases.\n\nThis is a randomized, crossover study where each participant will participate in 1 study day.\n\nTen healthy male participants in the age group 20-60 years are screened and randomized, and expected to complete the present study. Informed consent is obtained before the screening meeting.\n\nAll participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol + 2 mmol\u002Fkg sodium for 4 days before the experiment. On the fourth day, 24-hour urine collection will be performed. Throughout the 4 day period, water intake will be ad libitum and physical activity will not be allowed.\n\nEach participant will undergo both PET\u002FCT and MRI separated by around 1.5 hour.\n\nTotal renal blood flow and regional renal perfusion are measured repeatedly altogether 5 times with both PET\u002FCT and MRI. Renal oxygenation and oxygen extraction are measured repeatedly 5 times as well, using MRI. The 5 measurements consist of 2 at baseline (rest), 2 during isometric exercise (handgrip) and 1 during recovery (rest).\n\nIsometric muscle exercise is conducted by squeezing a handgrip coupled to a dynamometer. This increases sympathetic nervous activity, leading to preglomerular vasoconstriction.",[36,42],{"label":37,"type":6,"description":38,"interventionNames":39},"Group randomized to begin with MRI","Group is randomized to begin with MRI and have PET\u002FCT performed later on the same day",[40,41],"Procedure: MRI","Procedure: PET\u002FCT",{"label":43,"type":6,"description":44,"interventionNames":45},"Group randomized to begin with PET\u002FCT","Group is randomized to begin with PET\u002FCT and have MRI performed later on the same day",[40,41],[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":26},"PROCEDURE","MRI","MRI will be performed",[37,43],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":26},"PET\u002FCT","PET\u002FCT will be performed",[37,43],[57],{"name":58,"affiliation":59,"role":60},"Ali Asmar, MD, PhD","Bispebjerg Hospital, Department of Clinical Physiology and Nuclear Medicine","PRINCIPAL_INVESTIGATOR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":26,"email":66},"Peter Sørensen, MD","CONTACT","+4530516279","peter.soerensen@regionh.dk",{"name":58,"role":64,"phone":26,"phoneExt":26,"email":68},"ali.asmar@regionh.dk",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine","RECRUITING","Copenhagen","Capital Region","2400","Denmark","DK",{"type":79,"coordinates":80},"Point",[81,82],12.56553,55.67594,{"lat":82,"lon":81},[85,86],{"name":63,"role":64,"phone":65,"phoneExt":26,"email":66},{"name":58,"role":64,"phone":26,"phoneExt":26,"email":68},{"type":60,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Ali Asmar","Chief Physician, Associate Professor","100558752",false,"NCT06555211","Cardio and Renovascular Effects of Isometric Exercise in the Healthy Human Measured by PET\u002FCT and MRI","Cardio and Renovascular Effects of Static Muscle Work in the Healthy Human - Measured With Finapres® and Positron Emission Tomography (PET) Using 15-oxygen Labeled Water as Tracer Compared to Magnetic Resonance (MR)","Inclusion Criteria:\n\n* Normal health stated through medical questionnaire, examination and blood samples.\n\nExclusion Criteria:\n\n* Immunosuppressive treatment\n* Alcohol abuse\n* Treatment with glucocorticoids, Glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl peptidase 4 (DPP-4)-inhibitors\n* Medical treatment affecting insulin secretion or cardiovascular endpoints\n* Liver disease\n* Decreased kidney function\n* Severe claustrophobia\n* Elements incompatible with MR.",true,"MALE","18 Years","60 Years",{"count":101,"type":102},10,"ESTIMATED","INTERVENTIONAL",[105],"NA","This randomized crossover study aims to validate measurements of renal perfusion in healthy males with PET\u002FCT, using 15-oxygen labeled water as tracer, against the validated multiparametric MRI technique.\n\nThe study will determine:\n\n* Total renal blood flow and regional renal perfusion at baseline (rest) and during isometric muscle exercise of the upper arm, using PET\u002FCT (with 15-oxygen labeled water as a tracer) and MRI.\n* The coefficient of variation of renal blood flow and regional renal perfusion measurements at baseline and during isometric muscle exercise of the upper arm, using PET\u002FCT (with 15-oxygen labeled water as a tracer) and MRI.\n* Regional renal oxygenation and oxygen extraction at baseline and during isometric muscle exercise of the upper arm using MRI.\n* The coefficient of variation on regional renal oxygenation and oxygen extraction measurements at baseline and during isometric muscle exercise of the upper arm using MRI.",[108],"Kidneys",[110,111,112,113],"Total renal blood flow","Regional renal perfusion","Regional renal oxygenation","Renal oxygen extraction","2024-08-12",{"date":116,"type":117},"2024-08-15","ACTUAL",{"date":119,"type":117},"2024-05-07",{"date":121,"type":102},"2024-12",{"name":5,"class":6},1]