[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512712":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":53,"collaborators":23,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":23,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":23,"enrollmentInfo":66,"targetDuration":23,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":23,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with liver disease","EXPERIMENTAL","patients with chronic liver disease will receive a oral dose of a stable isotope labeled amino acid, 2H5-Phenylalanine, (45 mg\u002Fkg body weight 50% MPE).\n\nBlood samples will be taken over 12 weeks.",[13],"Other: stable isotopes",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy volunteers with no signs of liver disease","Healthy volunteers with no signs of liver disease will receive a oral dose of a stable isotope labeled amino acid, 2H5-Phenylalanine, (45 mg\u002Fkg body weight 50% MPE).\n\nBlood samples will be taken over 12 weeks.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"stable isotopes","The tracer 2H5-phenylalanine is an essential amino acid labeled with deuterium that is a stable isotope, i.e. no radiation is emitted, but the tracer can still be assessed by a combination of gas chromatography and mass spectrometry. The tracer has no measurable effects, but are used for assessment of human physiology.",[15,9],null,[25],{"name":26,"affiliation":27,"role":28},"Åke Norberg, PhD","Karolinska Institutet, Stockholm","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},"CONTACT","+46739669523","ake.norberg@ki.se",{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},"Olav Rooyackers, Professor","+46739661645","olav.rooyackers@ki.se",[39],{"facility":5,"status":23,"city":40,"state":23,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Stockholm","14186","Sweden","SE",{"type":45,"coordinates":46},"Point",[47,48],18.06871,59.32938,{"lat":48,"lon":47},[51,52],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Ake Norberg","Associate professor, senior consultant","100512712","albumin-catabolic-rate-measured-by-a-stable-isotope-100512712",false,"NCT05956015","Albumin Catabolic Rate Measured by a Stable Isotope","Inclusion Criteria:\n\nHealthy volunteers:\n\n* males and females \\>= 40 years (to be more like the anticipated age of the liver patients)\n* good peripheral blood vessels\n* written informed consent\n\nPatients with liver cirrhosis:\n\n* known compensated liver cirrhosis with radiological or endoscopic signs of portal hypertension, such as varices, splenomegaly, or shunts.\n* written informed consent\n\nExclusion Criteria:\n\n* Planned surgical procedure within 3 months (due to possible blood loss i.e. loss of tracer)\n* Pregnancy at dosing\n* Phenylketonuria\n* Participating in other study with stable isotopes within 60 days.\n* Circumstance that causes the responsible researcher to assess the research person's participation as inappropriate",true,"ALL","40 Years",{"count":67,"type":68},24,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this physiological study is to compare albumin catabolic rate measured by a stable isotope labeled amino acid in healthy volunteers and in patients with liver disease. At steady state synthesis and catabolism or degradation are equal.\n\nThe primary questions it aims to answer are:\n\n* Is albumin catabolic rate lower in patients with liver disease?\n* Is albumin catabolic rate measured by stable isotopes in volunteers like historical controls measured by radio-iodinated albumin at the investigator's laboratory or elsewhere? Subjects will be given an oral dose of the deuterium labeled amino acid phenylalanine that will be incorporated by the liver in newly synthetized albumin molecules, and blood samples will be taken over 12 weeks to determine the catabolic rate of albumin.",[74],"Liver Disease Chronic",[76],"albumin catabolism","NOT_YET_RECRUITING","2023-07-23",{"date":80,"type":81},"2023-07-25","ACTUAL",{"date":83,"type":68},"2023-08-28",{"date":85,"type":68},"2028-12-31",{"name":55,"class":6},1]