[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refeeding-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refeeding-syndrome":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,76,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100644691","gastrointestinal-hormones-and-metabolomic-profiling-following-mixed-meal-tolerance-tests-in-patients-at-risk-of-refeeding-syndrome-100644691",false,"NCT07674589","Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome","Combined Assessment of Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at High Risk of Refeeding Syndrome: Study Protocol","Inclusion Criteria:\n\n* Age above 18 years.\n* Oral ingestion below 50% of energy daily needs for ≥ 1 month.\n* Absence of artificial nutrition before PEG placement.\n\nExclusion Criteria:\n\n* Age below 18 years.\n* Quantified food ingestion above 50% of energy daily needs during the last month.\n* Oncologic disease.\n* Diabetes mellitus.\n* Expected survival below 3 months.\n* Inability to provide credible anamnestic data.\n* Impossibility to have an appropriate clinical and nutritional follow-up.","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","OBSERVATIONAL","Introduction: Refeeding syndrome (RS) is a life-threatening metabolic complication of nutritional support. Prolonged fasting, frequently observed in malnourished patients referred for percutaneous endoscopic gastrostomy (PEG), induces histological and ultrastructural changes in the intestinal mucosa, potentially influencing RS development. Mixed-Meal Tolerance Tests (MMTT) combined with metabolomics allow dynamic assessment of serum glucose, gastrointestinal hormones and cellular metabolites, which may help to elucidate RS pathogenesis and assess patient risk. Objective: The present study aims to perform MMTT in PEG-fed patients to evaluate enteroendocrine hormone responses and metabolomic profiles following a prolonged fasting period and subsequent enteral refeeding. Methods: This prospective, single-center study includes adults referred for PEG after at least one month of oral intake below 50% of energy needs. The MMTT will be performed at PEG placement and after 3-6 months of enteral nutrition. Serial blood samples will be collected from baseline up to 120 minutes post-meal to measure serum glucose, insulin, C-peptide, electrolytes and gastrointestinal hormones (GLP-1\u002FGIP\u002FGhrelin\u002FPeptide YY), and for metabolomic profiling by spectroscopy. Clinical and nutritional data will be prospectively recorded. Statistical and multivariate analyses will assess metabolic and hormonal changes over time and their potential association with patient refeeding syndrome risk and clinical outcome. The study was approved by the institutional ethics committee, and patient informed consent will be obtained. Conclusion: This study integrates MMTT and metabolomic profiling to characterize hormonal and metabolic responses during fasting and refeeding in high-risk PEG patients. Findings are expected to reveal underlying mechanisms of RS, identify potential predictive biomarkers, and improve individualized risk stratification and nutritional management.",[24,25],"Refeeding Syndrome","Malnutrition",[24,27,28,29,30],"Gastrointestinal Hormones","Metabolomics","Mixed-Meal Tolerance Tests","PEG","NOT_YET_RECRUITING","2026-06-25",{"date":34,"type":35},"2026-06-29","ACTUAL",{"date":37,"type":20},"2026-07",{"date":39,"type":20},"2027-07",{"name":41,"class":42},"Hospital Garcia de Orta","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100579521","comparing-high-protein-vs-standard-protein-nutritional-support-in-critically-ill-patients-at-risk-for-refeeding-syndrome-100579521","NCT06825377","Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome","Comparing the Effects of High-protein Nutritional Support with Standard Protein Nutritional Support Through the Administration of Whey Protein Supplements on Clinical Outcomes of Critically Ill Patients At Risk for Refeeding Syndrome: a Randomized Comparative Clinical Trial","Inclusion Criteria:\n\n* Willingness to cooperate and complete the informed consent form by the patient or legal guardian;\n* age ≤ 18 years and \\\u003C 65 years;\n* Non-pregnant and non-lactating;\n* Serum creatinine ≥ 1.1 mg\u002Fdl for women and ≥ 1.2 mg\u002Fdl for men;\n* No organ failure at the time of study enrollment;\n* Intervention initiation within 48 hours of ICU admission;\n* No history of metastatic cancer or end-stage disease;\n* No absolute contraindications to enteral nutrition (e.g., persistent ileus, gastrointestinal ischemia, persistent or biliary vomiting, mechanical obstruction);\n* No active infections, sepsis, severe sepsis, or septic shock;\n* No intolerance to the whey protein supplement used in the current study;\n* Not participating in other clinical trials concurrently with this study;\n* No clinical conditions with higher or lower protein needs, such as burns, sepsis, cirrhosis, or chronic kidney disease;\n* No diabetes with severe complications such as ketoacidosis, hyperosmolar coma, or acidosis.\n\nExclusion Criteria:\n\n* Unwillingness to continue cooperation during study;\n* Discharge or death of the patient earlier than 5 days from the start of the intervention;\n* Occurrence of side effects during the study","65 Years",{"count":53,"type":20},150,"INTERVENTIONAL",[56],"NA","The goal of this clinical trial is to determine the optimal protein administration strategy for enhancing both nutritional and clinical outcomes, as well as reducing complications and mortality in ICU patients at risk for refeeding syndrome (RS). This study will include critically ill patients at risk for RS who are receiving supportive nutrition. The primary hypothesis is that higher protein intake will lead to a decreased incidence of refeeding syndrome. It is also expected that patients receiving more protein will have better clinical outcomes, lower mortality, and shorter ICU and hospital stays.",[59,25,24,60],"Critical Illness","At Risk for Refeeding Syndrome",[62,63,64,65,25,66],"Refeeding syndrome","Critically ill","High-protein","Complication","mortality","RECRUITING","2025-02-13",{"date":70,"type":35},"2025-02-14",{"date":68,"type":35},{"date":73,"type":20},"2026-04-15",{"name":75,"class":42},"Shahid Beheshti University",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100561385","prevention-of-refeeding-syndrome-100561385","NCT06589479","Prevention of Refeeding Syndrome","Effects of Different Caloric Density Intake in Prevention of Refeeding Syndrome in Critically Ill Children","Inclusion Criteria:\n\n1. Chidren from one month up to less than 5 years.\n2. Starvation (long term parenteral or IV fluid) for at least 3 days.\n3. Patients at risk of refeeding syndrome according to ASPEN criteria.\\[11\\]\n\nExclusion Criteria:\n\n1. Children below one month and above 5 years.\n2. Carless or lack of compliance of parents or psychological problems.","1 Month","5 Years",{"count":86,"type":20},50,"To determine effects of different caloric density intake in prevention of refeeding syndrome in critically ill children",[24],"2024-09-09",{"date":91,"type":35},"2024-09-19",{"date":93,"type":20},"2024-10-01",{"date":95,"type":20},"2026-03-31",{"name":97,"class":42},"Assiut University",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":17,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100560959","refeeding-syndrome-in-critically-ill-children-100560959","NCT06583928","Refeeding Syndrome in Critically Ill Children","Frequency of Refeeding Syndrome in Critically Ill Children At Assiut University Hospital","Inclusion Criteria:\n\n* Children included were those (1month to 18 years) admitted at hospital with minimum of one phosphorus, potassium, and\u002For magnesium assay and who are severely malnourished and starved (no feeding )for at least 3 days then received exclusive or supplemental nutritional support.\n\nUndernourished children (body mass index z-score \\< -2 standard deviations) were considered at risk of refeeding syndrome. The ASPEN critiera were used to identify those with probable refeeding syndrome.\n\nExclusion Criteria:\n\n* Patients age less than 1month and more than 18 years' old and patients with CKD ,liver cirrhosis and endocrinal diseases.",{"count":106,"type":20},54,"Refeeding syndrome (RFS) is the a metabolic disturbance which occurs as a result of reinstitution of nutrition in people who are starved, severely malnourished, or metabolically stressed because of severe illness. When too much food or liquid nutrition supplement is eaten during the initial three to seven days following a malnutrition event, the production of glycogen, fat and protein in cells may cause low serum concentrations of potassium, magnesium and phosphate.",[24,109],"Syndrome, Refeeding","2024-09-04",{"date":91,"type":35},{"date":93,"type":20},{"date":114,"type":20},"2025-12-01",{"name":97,"class":42}]