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Resting Energy Expenditure by Gastrointestinal Functional Status

RecruitingNAAges 18 Years - 65 YearsAllInstitute of Oncology Ljubljana
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In plain words

What the trial is, and whether it could suit you

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. Participants 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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Group A - Healthy Controls: * Age 18 to 65 years * No diagnosed chronic diseases * No hospitalization within the previous 30 days * No acute illness within the previous 14 days Group B - Participants With Intestinal Failure: * Age 18 to 65 years * Diagnostically confirmed intestinal failure * Stable clinical condition Exclusion Criteria: * Uncontrolled hyperthyroidism or hypothyroidism * Diabetes mellitus with poor glycemic control * Adrenal gland disease * Active inflammatory bowel disease, including Crohn's disease or ulcerative colitis * Celiac disease * Chronic pancreatitis * Active gastric or esophageal disease * Irritable bowel syndrome with significant symptoms * 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 * Heart failure * Active ischemic heart disease or recent myocardial infarction * Chronic obstructive pulmonary disease * Respiratory failure or need for long-term oxygen therapy * Progressive neurodegenerative disease * Dementia impairing the ability to participate * Severe stroke with significant functional impairment * Active tuberculosis * HIV/AIDS with clinically significant immunosuppression * Active systemic autoimmune disease * Active malignant disease * Advanced liver cirrhosis * Chronic kidney disease * Treatment with hemodialysis or peritoneal dialysis * Pregnancy or breastfeeding
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What it tests

  • Protocol-Defined Metabolic and Body Composition Assessment
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Where

1 site
Institute of Oncology Ljubljana
Ljubljana, Slovenia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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