Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:49 AM
Study NCT ID:
NCT01307306
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2011-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucose Control in Severely Burned Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D002057', 'term': 'Burns, Chemical'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'D008687', 'term': 'Metformin'}], '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'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2011-01-21', 'studyFirstSubmitQcDate': '2011-02-28', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perform oral glucose tolerance test', 'timeFrame': 'at 1-2 months post-admission, up to 6 months', 'description': 'Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.'}, {'measure': 'Perform oral glucose tolerance test', 'timeFrame': 'assessed at discharge (1-4 months post admission depending on the severity of injury)', 'description': 'Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.'}], 'secondaryOutcomes': [{'measure': 'Measure concentrations of serum cytokines', 'timeFrame': 'weekly until discharge (1-4 months post admission depending on severity of injury)', 'description': 'Inflammatory response will be assessed by measuring the concentrations (in pg/ml)of a panel of serum cytokines (IL-1, IFN, TNF etc.) using the Bio-Plex 17-Plex Suspension assay.'}, {'measure': 'Record the episodes of sepsis', 'timeFrame': 'daily until discharge (1-4 months post admission depending on severity of injury)', 'description': 'Patients will be assessed daily for episodes of sepsis. The total number of episodes over the course of hospital stay will be recorded.'}, {'measure': 'Record the episodes of Pneumonia', 'timeFrame': 'daily until discharge (1-4 months post admission depending on severity of injury)', 'description': 'Pneumonia is defined by new progressive and persistent infiltrate, consolidation or cavitations, inhalation injury based on chest X-ray. We will also follow the guidelines provided by the American Burn Association on the definition of Pneumonia in burn patients. Change in sputum (purulent or increased) will also be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thermal injury', 'Chemical Burn', 'Flame Burn'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'The central aim of this application is to determine whether improved outcomes with tight euglycemic control are due to insulin-specific responses. The investigators hypothesize that improving insulin resistance will lead to decreased inflammatory and hypermetabolic responses, as well as restored glucose metabolism, and so result in improved clinical outcome of severely burned patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 and 90 years of age\n* \\>20% TBSA\n* Admitted to the burn unit within 120 hours following burn\n* At least 1 surgical intervention necessary\n\nExclusion Criteria:\n\n* death upon admission\n* decision not to treat due to burn injury severity\n* presence of anoxic brain injury that is not expected to result in complete recovery\n* known history of AIDS, ARC, HIV, Hepatitis B-E\n* history of cancer within 5 years of malignancy currently under treatment\n* inability to obtain informed consent\n* previous or existing renal dysfunction, liver disease, or hepatic dysfunction\n* pre-existing type I diabetes mellitus\n* pregnancy\n* allergy to metformin'}, 'identificationModule': {'nctId': 'NCT01307306', 'briefTitle': 'Glucose Control in Severely Burned Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential', 'orgStudyIdInfo': {'id': 'ins_met_jeschke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin', 'interventionNames': ['Drug: Humulin R']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Humulin R', 'type': 'DRUG', 'description': 'Humulin R (U-100) will be given i.v. The dose given will be adjusted in order to achieve a blood glucose level of 130-140 mg/dl.', 'armGroupLabels': ['Insulin']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Marc G Jeschke, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Marc Jeschke', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}