[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647980":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":34,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Controls","ACTIVE_COMPARATOR","Adults with normal gastrointestinal function who serve as the comparison group. Participants undergo the protocol-defined metabolic, body-composition, and laboratory assessments during a single study visit, including indirect calorimetry after fasting, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers.",[13],"Diagnostic Test: Protocol-Defined Metabolic and Body Composition Assessment",{"label":15,"type":16,"description":17,"interventionNames":18},"Participants With Intestinal Failure","EXPERIMENTAL","Adults with clinically confirmed intestinal failure, including participants with short bowel syndrome and participants with other causes of intestinal failure. Participants undergo the protocol-defined metabolic, body-composition, and laboratory assessments during a single study visit, including indirect calorimetry after fasting, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Protocol-Defined Metabolic and Body Composition Assessment","Participants undergo a standardized research assessment during one study visit. Resting energy expenditure is measured by indirect calorimetry after fasting. Body composition is assessed by dual-energy X-ray absorptiometry and bioelectrical impedance analysis. Blood samples are collected for the assessment of inflammatory markers. These assessments are performed outside routine clinical care according to the study protocol.",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Klemen Schara, MSc","CONTACT","+38631630065","kschara@onko-i.si",[33],{"facility":5,"status":34,"city":35,"state":25,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":40,"coordinates":41},"Point",[42,43],14.50513,46.05108,{"lat":43,"lon":42},[46],{"name":47,"role":29,"phone":48,"phoneExt":25,"email":31},"Klemen Salmič, MSc","+386 1 587 9526",{"type":50,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100647980","resting-energy-expenditure-by-gastrointestinal-functional-status-100647980",false,"NCT07714499","Resting Energy Expenditure by Gastrointestinal Functional Status","Comparison of Resting Energy Expenditure According to Gastrointestinal Functional Status","Inclusion Criteria:\n\nGroup A - Healthy Controls:\n\n* Age 18 to 65 years\n* No diagnosed chronic diseases\n* No hospitalization within the previous 30 days\n* No acute illness within the previous 14 days\n\nGroup B - Participants With Intestinal Failure:\n\n* Age 18 to 65 years\n* Diagnostically confirmed intestinal failure\n* Stable clinical condition\n\nExclusion Criteria:\n\n* Uncontrolled hyperthyroidism or hypothyroidism\n* Diabetes mellitus with poor glycemic control\n* Adrenal gland disease\n* Active inflammatory bowel disease, including Crohn's disease or ulcerative colitis\n* Celiac disease\n* Chronic pancreatitis\n* Active gastric or esophageal disease\n* Irritable bowel syndrome with significant symptoms\n* History of major abdominal surgery that permanently affects gastrointestinal function, except in participants with intestinal failure when this forms part of the condition under study\n* Heart failure\n* Active ischemic heart disease or recent myocardial infarction\n* Chronic obstructive pulmonary disease\n* Respiratory failure or need for long-term oxygen therapy\n* Progressive neurodegenerative disease\n* Dementia impairing the ability to participate\n* Severe stroke with significant functional impairment\n* Active tuberculosis\n* HIV\u002FAIDS with clinically significant immunosuppression\n* Active systemic autoimmune disease\n* Active malignant disease\n* Advanced liver cirrhosis\n* Chronic kidney disease\n* Treatment with hemodialysis or peritoneal dialysis\n* Pregnancy or breastfeeding",true,"ALL","18 Years","65 Years",{"count":63,"type":64},92,"ESTIMATED","INTERVENTIONAL",[67],"NA","This prospective, comparative interventional study will evaluate resting energy expenditure in adults with different gastrointestinal functional status. A total of 92 participants aged 18 to 65 years will be included: 30 healthy adults with normal gastrointestinal function and 62 patients with clinically confirmed intestinal failure. The intestinal failure group will include patients with short bowel syndrome and patients with other causes of intestinal failure.\n\nParticipants will be assigned to one of two protocol-defined groups according to their gastrointestinal functional status. Each participant will attend one study visit lasting approximately 90 to 120 minutes. The research procedures will include measurement of resting energy expenditure by indirect calorimetry after an overnight fast, assessment of body composition by dual-energy X-ray absorptiometry and bioelectrical impedance analysis, and blood sampling for inflammatory markers.\n\nThe primary objective is to compare resting energy expenditure between healthy participants and patients with intestinal failure and to determine whether resting energy expenditure differs according to the underlying cause of intestinal failure. Secondary objectives are to evaluate the associations between resting energy expenditure, lean body mass, fat mass, phase angle, and inflammatory markers. The results may contribute to more individualized nutritional management of patients with intestinal failure.",[70,71],"Intestinal Failure","Short Bowel Syndrome",[73,74,75,76],"Resting Energy Expenditure","Indirect Calorimetry","Body Composition","Dual-Energy X-Ray Absorptiometry","2026-07-15",{"date":79,"type":80},"2026-07-20","ACTUAL",{"date":82,"type":80},"2025-10-01",{"date":84,"type":64},"2026-10-01",{"name":5,"class":6},1]