[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100303093":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":16,"studyPopulation":17,"armGroups":18,"interventions":28,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":13,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":13,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":13,"enrollmentInfo":74,"targetDuration":13,"studyType":77,"phases":13,"briefSummary":78,"conditions":79,"keywords":13,"overallStatus":47,"whyStopped":13,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Fractional Synthesis Rate","Fractional synthesis rate (FSR)for each patient is measured by the rate of tracer incorporation from the MIF pool to the bound pool.","4 hours",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":6,"maskingInfo":13},"CASE_CONTROL","The goal of this study is to identify the molecular regulatory mechanisms that result in loss of skeletal muscle in cirrhotic patients. Current strategies involve prolonged tracer infusion and multiple muscle biopsies. We will use an innovative approach to determine the rates of skeletal muscle protein synthesis and breakdown using multiple tracers administered at short intervals followed by a single muscle biopsy. These studies are likely to provide a conceptual advance in determining the cellular and molecular responses of the skeletal muscle in cirrhosis.","Study population: Adults with the diagnosis of cirrhosis will be recruited from the hepatology inpatient service, outpatient clinics and liver transplant clinics at the Cleveland Clinic Foundation. The diagnosis of cirrhosis will be based on liver biopsy and\u002For clinical, biochemical, and imaging criteria. Will include patient with Child Pugh score from A5- to B7",[19,24],{"label":20,"type":13,"description":21,"interventionNames":22},"Patients with Cirrhosis","Patients with a diagnosis of cirrhosis will have a blood draw and muscle biopsy will be performed.",[23],"Procedure: blood draw and muscle biopsy",{"label":25,"type":13,"description":26,"interventionNames":27},"controls","control group should have serum ALT and AST within normal range and a blood draw and muscle biopsy will be performed",[23],[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"PROCEDURE","blood draw and muscle biopsy","One venous catheter will be used for bolus injection of multiple labeled AA at the beginning .The second venous catheter will inserted in the other arm for 5 ml of arterialized venous blood draw.Following the infusions, a single muscle biopsy will be performed from the vastus lateralis of the thigh using the Bergstromm needle.",[20,25],[35],{"name":36,"affiliation":5,"role":37},"Srinivasan Dasarathy, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},"Annette Bellar, MSLA","CONTACT","2164450688","bellara@ccf.org",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Cleveland Clinic Foundation","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-81.69541,41.4995,{"lat":57,"lon":56},[60],{"name":40,"role":41,"phone":61,"phoneExt":13,"email":43},"216-445-0688",{"type":37,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Srinivasan Dasarathy","Principal Investigator","100303093","novel-tracer-methods-to-evaluate-muscle-protein-metabolism-in-cirrhosis-100303093",false,"NCT03225677","Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis","Multiple Tracer Using Single Muscle Biopsy Technique in Evaluating Protein Synthesis and Break Down in Muscles of Cirrhotic Patients","Inclusion Criteria:\n\n* The diagnosis of cirrhosis based on liver biopsy and\u002For clinical, biochemical, and imaging criteria.\n* Patients with Child Pugh score from A5- to B7\n* Control group: Subject in control group should have serum ALT and AST within normal range.\n\nExclusion Criteria for both groups (cirrhotic and control) are:\n\n* diabetes\n* cancer\n* kidney failure\n* pregnancy\n* recent surgery (bowel resection or Gastric bypass operation)\n* Advanced cardiac or pulmonary disease\n* patient with thyroid disease \\& Coagulopathy ( INR \\>1.4 and platelet count \\\u003C80,000\u002Fml)","ALL","18 Years",{"count":75,"type":76},20,"ESTIMATED","OBSERVATIONAL","To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.",[80],"Cirrhosis","2026-09-23",{"date":83,"type":84},"2026-09-24","ACTUAL",{"date":86,"type":84},"2017-08-03",{"date":88,"type":76},"2028-09-30",{"name":5,"class":6},1]