Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-05 @ 1:06 PM
Study NCT ID:
NCT02029261
Status:
WITHDRAWN
Last Update Posted:
2019-03-07
First Post:
2013-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood, plasma, isolated leukocytes, skeletal muscle, fat, skin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of gene expression profile and protein expression', 'timeFrame': 'Time of burn injury up to 24 months postinjury', 'description': 'Determination of individual profiles and comparison with profiles from existing patients and healthy controls'}], 'secondaryOutcomes': [{'measure': 'Hospital discharge status', 'timeFrame': 'From hospital admission to discharge', 'description': 'Alive or dead'}, {'measure': 'Presence of clinical complications', 'timeFrame': 'From hospital admission to discharge', 'description': 'Analysis of incidence of clinical complications related to organ function/dysfunction'}, {'measure': 'Intensive care unit (ICU) days', 'timeFrame': 'From hospital admission to discharge', 'description': 'Total number of ICU days'}, {'measure': 'Nutritional status at discharge', 'timeFrame': 'At hospital discharge', 'description': 'Analysis of change in total body weight, lean body mass, indirect calorimetry, and nitrogen balance'}, {'measure': 'Correlation between protein data and in vivo physiologic measurement data', 'timeFrame': 'Hospitalization', 'description': 'Gene and and protein expression data will be correlated with the physiological and and in vivo physiologic measurements (lab values) and nutritional status data.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Burn'], 'conditions': ['Burn']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine important and significant problems, that of insulin resistance and muscle wasting after burn injury.', 'detailedDescription': 'Burn injury induces insulin resistance and our investigators have previous shown the importance of insulin receptor substrate 1 (IRS-1)-mediated pathways. This project will establish the inhibitory effects of burn injury on IRS-1 mediated signaling in human skeletal muscle of burn patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Massachusetts General Hospital (MGH) burn patients from the emergency department, intensive care unit, burn unit, or other MGH inpatient unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Burn injury \\>=10% total body surface area involvement from any etiology that will require surgical treatment\n* Age 18 years or older\n* Admitted to the Massachusetts General Hospital within 30 days of burn injury\n* Patient or guardian who is capable of giving full informed consent\n\nExclusion Criteria:\n\n* Decision not to treat due to severity of injury\n* Presence of anoxic brain injury that is not expected to result in complete recovery\n* Existence of co-morbid conditions of malignancy currently under treatment, medical condition requiring glucocorticoid treatment, insulin dependent diabetes mellitus, morbid obesity defined as body mass index \\>= 40'}, 'identificationModule': {'nctId': 'NCT02029261', 'briefTitle': 'Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Project 4: Molecular Mechanisms in Burn-induced Insulin Resistance in Humans', 'orgStudyIdInfo': {'id': 'P50GM021700P4_1'}, 'secondaryIdInfos': [{'id': '2P50GM021700-32A1', 'link': 'https://reporter.nih.gov/quickSearch/2P50GM021700-32A1', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ronald G Tompkins, MD, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data provided to the journal as required for publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Burns Division', 'investigatorFullName': 'Ronald G. Tompkins', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}