Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT05487833
Status:
UNKNOWN
Last Update Posted:
2022-11-01
First Post:
2022-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '%triglyceride reduction', 'timeFrame': 'after 18 hours of treatment', 'description': 'change in triglycerides, expressed as % of initial value'}], 'secondaryOutcomes': [{'measure': 'incidence of hypoglycemia', 'timeFrame': 'during treatment with insulin, up to day 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertriglyceridemia', 'Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute pancreatitis\n* triglycerides \\> 15 mmol/l\n\nExclusion Criteria:\n\n* diabetes on peroral therapy or insulin\n* blood glucose \\> 11 mmol/l\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT05487833', 'briefTitle': 'Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Comparison of Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis in Patients Without Diabetes', 'orgStudyIdInfo': {'id': 'InzulinHTGAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'insulin', 'interventionNames': ['Biological: insulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'standard management', 'interventionNames': ['Other: standard treatment']}], 'interventions': [{'name': 'insulin', 'type': 'BIOLOGICAL', 'description': '5% glucose in 0.9% NaCl with 4 IU of short acting insulin per 500 ml added, infused at a rate determined by the treating physician, treatment duration: 18 hours', 'armGroupLabels': ['insulin']}, {'name': 'standard treatment', 'type': 'OTHER', 'description': 'infusion of a balanced solution, infused at a rate determined by the treating physician, treatment duration: 18 hours', 'armGroupLabels': ['standard management']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Samo Plut, MD', 'role': 'CONTACT', 'email': 'samo.plut@kclj.si', 'phone': '00386 1 522 4165'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'deidentified IPD that underlie results in a publication will be available from the corresponding author on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jakob Gubensek', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}