Intestinal Failure, Short Bowel Syndrome
Conditions
Keywords
Resting Energy Expenditure, Indirect Calorimetry, Body Composition, Dual-Energy X-Ray Absorptiometry
Brief summary
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 analysis, and blood sampling for inflammatory markers. The 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.
Detailed description
Intestinal failure is a condition in which the gastrointestinal tract is unable to provide adequate digestion and absorption of nutrients, electrolytes, and fluids. Patients may therefore require partial or complete parenteral nutrition. Their resting energy expenditure may be affected by the underlying cause of intestinal failure, changes in body composition, nutritional and metabolic status, and systemic inflammation. Accurate assessment of energy requirements is important for planning individualized nutritional support. This is a prospective, comparative interventional study with two non-randomized, protocol-defined groups. Group A will include 30 healthy adults with normal gastrointestinal function. Group B will include 62 clinically stable patients with confirmed intestinal failure. Within Group B, approximately 38 participants will have short bowel syndrome and 24 will have other causes of type II or type III intestinal failure, including chronic intestinal dysmotility or extensive disease of the small intestinal mucosa. The study intervention consists of metabolic, body-composition, and laboratory assessments performed according to a standardized research protocol. Each participant will complete the study during one visit at the Institute of Oncology Ljubljana. The visit will last approximately 90 to 120 minutes. Resting energy expenditure will be measured in the morning, after fasting, in a thermoneutral environment using indirect calorimetry. The indirect calorimetry measurement will last approximately 30 minutes and will determine oxygen consumption and carbon dioxide production. Body composition will be assessed using dual-energy X-ray absorptiometry to measure lean body mass, fat mass, and bone mineral density. Bioelectrical impedance analysis will also be performed to determine phase angle as an indicator of cellular integrity and function. A blood sample will be collected to assess inflammatory markers, including C-reactive protein and calculated neutrophil-to-lymphocyte, platelet-to-lymphocyte, and lymphocyte-to-monocyte ratios. Resting energy expenditure will be evaluated as an absolute value in kilocalories per day and in standardized forms, including adjustment for lean body mass, age, and sex. The primary analyses will compare resting energy expenditure between healthy participants and patients with intestinal failure and between patients with short bowel syndrome and patients with other causes of intestinal failure. Secondary analyses will examine the associations between resting energy expenditure and body-composition parameters, phase angle, and inflammatory markers. The study is intended to improve understanding of metabolic requirements in intestinal failure and to support the development of more individualized nutritional recommendations for these patients.
Interventions
DIAGNOSTIC_TESTProtocol-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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants are enrolled non-randomly into one of two parallel groups based on their pre-existing gastrointestinal functional status: healthy controls with normal gastrointestinal function and patients with intestinal failure. Both groups undergo the same protocol-defined assessments during a single study visit, including indirect calorimetry, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resting Energy Expenditure Measured by Indirect Calorimetry | During the single study visit; REE is assessed over approximately 30 minutes | Resting energy expenditure (REE) will be measured by indirect calorimetry in the morning after fasting and under thermoneutral conditions. The measurement will last approximately 30 minutes and REE will be expressed as an absolute value in kilocalories per day. REE will also be standardized according to lean body mass and evaluated according to age and sex. Values will be compared between healthy controls and participants with intestinal failure, as well as between participants with short bowel syndrome and participants with other causes of intestinal failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry | During the single study visit, lasting approximately 90 to 120 minutes | Lean body mass will be measured by dual-energy X-ray absorptiometry (DXA). The association between lean body mass and resting energy expenditure will be analyzed in all participants. |
| Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry | During the single study visit, lasting approximately 90 to 120 minutes | Fat mass will be measured by dual-energy X-ray absorptiometry (DXA). The association between fat mass and resting energy expenditure will be analyzed in all participants. |
| Phase Angle Assessed by Bioelectrical Impedance Analysis | During the single study visit, lasting approximately 90 to 120 minutes | Phase angle will be measured by bioelectrical impedance analysis (BIA) as an indicator of cellular integrity and function. The association between phase angle and resting energy expenditure will be analyzed in healthy controls and participants with intestinal failure. |
| C-Reactive Protein | During the single study visit, lasting approximately 90 to 120 minutes | C-reactive protein concentration will be determined from a blood sample as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure. |
| Neutrophil-to-Lymphocyte Ratio | During the single study visit, lasting approximately 90 to 120 minutes | The neutrophil-to-lymphocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure. |
| Platelet-to-Lymphocyte Ratio | During the single study visit, lasting approximately 90 to 120 minutes | The platelet-to-lymphocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure. |
| Lymphocyte-to-Monocyte Ratio | During the single study visit, lasting approximately 90 to 120 minutes | The lymphocyte-to-monocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure. |
Countries
Slovenia
Contacts
CONTACTKlemen Schara, MSc
Outcome results
None listed