Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04530058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-02
First Post:
2020-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Metformin on Morbidity and Mortality in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Record mortality', 'timeFrame': 'Acute hospitalization up to one year post burn.', 'description': 'Patient mortality will be recorded during hospitalization and outpatient follow-ups.'}, {'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 episodes of infection.', 'timeFrame': 'daily until discharge (1-4 months post admission depending on severity of injury)]', 'description': 'Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded.'}, {'measure': 'Record episodes of pneumonia.', 'timeFrame': 'daily until discharge (1-4 months post admission depending on severity of injury)]', 'description': 'Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded.'}, {'measure': 'Organ function - Alkaline phosphatase (ALP)', 'timeFrame': 'twice weekly until discharge (1-4 months post admission depending on severity of injury)]', 'description': 'Organ function will be assessed by measuring the biomarker: ALP (U/L).'}, {'measure': 'Organ function - Alanine transaminase (ALT)', 'timeFrame': 'twice weekly until discharge (1-4 months post admission depending on severity of injury)]', 'description': 'Organ function will be assessed by measuring the biomarker: ALT (U/L).'}, {'measure': 'Organ function - Bilirubin', 'timeFrame': 'twice weekly until discharge (1-4 months post admission depending on severity of injury)]', 'description': 'Organ function will be assessed by measuring the biomarker: bilirubin (umol).'}, {'measure': 'Organ function - Blood Urea Nitrogen (BUN)', 'timeFrame': 'twice weekly until discharge (1-4 months post admission depending on severity of injury)]', 'description': 'Organ function will be assessed by measuring the biomarker: BUN (mmol).'}, {'measure': 'Organ function - Creatinine', 'timeFrame': 'twice weekly until discharge (1-4 months post admission depending on severity of injury)]', 'description': 'Organ function will be assessed by measuring the biomarker: creatinine (umol/L).'}], 'secondaryOutcomes': [{'measure': 'Measures of steady-state resting energy expenditure (REE)', 'timeFrame': 'weekly until discharge if a patient is intubated and ventilated (1-4 months post admission depending on severity of injury)]', 'description': 'Metabolic response to injury and illness can be studied by measuring steady-state resting energy expenditure. Hypermetabolism is used as a secondary endpoint as stress-induced diabetes is associated with inflammation and hypermetabolism.'}, {'measure': 'Perform oral glucose tolerance test', 'timeFrame': 'once at discharge from hospital (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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'Elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. Elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.Glucose metabolism with insulin resistance is a hypermetabolic response pathway that profoundly affects post-burn outcomes. The aim if this study is to determine whether metformin can improve morbidity and mortality in elderly burn patients. The investigators hypothesize that metformin will improve clinical outcomes and mortality of elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 60 - 99 years of age.\n2. ≥5% total body surface area (TBSA) burn.\n3. Admitted to burn center ≤ 120 hours post-burn injury.\n4. At least one surgical intervention likely required.\n5. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Death upon admission.\n2. Decision not to treat due to burn injury severity.\n3. Presence of anoxic brain injury that is not expected to result in complete recovery.\n4. Pre-existing renal failure (eGFR is \\< 30 mL/min).\n5. Severe liver disease (Child-Pugh C).\n6. Pre-existing insulin-dependent type II diabetes.\n7. Clinical contraindication to give metformin.\n8. Allergy to metformin or insulin.\n9. History of lactic acidosis while receiving metformin treatment.'}, 'identificationModule': {'nctId': 'NCT04530058', 'acronym': 'MET-ELD', 'briefTitle': 'The Effects of Metformin on Morbidity and Mortality in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'The Effects of Metformin on Morbidity and Mortality in Elderly Patients- a Prospective Randomized Control Trial (RCT)', 'orgStudyIdInfo': {'id': '15230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin 500 mg twice a day, administered orally or via gastric tube.', 'armGroupLabels': ['Metformin']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo twice a day, administered orally or via gastric tube.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Marc G. Jeschke, MD PhD', 'role': 'CONTACT', 'email': 'marc.jeschke@hhsc.ca', 'phone': '905-521-2100', 'phoneExt': '40694'}, {'name': 'Marc G. Jeschke, MD PhD', 'role': 'CONTACT'}], 'facility': 'Hamilton Health Sciences Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Marc G Jeschke, MD PhD', 'role': 'CONTACT', 'email': 'marc.jeschke@hhsc.ca', 'phone': '905-521-2100', 'phoneExt': '40694'}], 'overallOfficials': [{'name': 'Marc G Jeschke, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}