Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-04-17 @ 1:29 PM
Study NCT ID:
NCT04969159
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2021-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Degree, Duration and Frequency of Insulin Resistance in Non-operated Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D014115', 'term': 'Toxemia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-09', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'continous blood glucose', 'timeFrame': '4 weeks', 'description': 'flash glucose monitor on the upper arm'}], 'secondaryOutcomes': [{'measure': 'C-peptide', 'timeFrame': '4 weeks', 'description': 'plasma concentration'}, {'measure': 'HOMA-IR', 'timeFrame': '4 weeks', 'description': 'calculated glucose load test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['septicaemia', 'insulin resitance', 'continous blood glucose'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Surgery induces insulin resistance lasting for 2-3 weeks. We wanted to elucidate if stress-metabolic, medical conditions carry the same effect.', 'detailedDescription': "Background: Insulin resistance is well documented after surgery in a severity positively correlated to the degree of trauma (Thorell et al. 1999; Chambrier et al. 2000). Similar phenomena have been described in severely ill patients in ICU with consequences for the survival (Van den Berghe et al. 2001; The NICE-SUGAR Study Investigators 2009). The documentation, however, is scarce and the extent is unknown in acutely ill patients with sepsis.\n\nMethod: Adult, consecutive, non-diabetic patients with elevated CRP, leukocyte counts, SOFA-score of ≥ 2 were monitored with fasting p-C-peptide, blood glucose, CRP, leukocyte count and HOMA-IR at admittance, discharge and at two follow-up visits 2 weeks and 4 weeks after admission. Blood glucose levels were measured continuously during the whole study period with a flash glucose monitor mounted on the patients' upper arm. The diagnosis was sepsis, urosepsis, pneumonia, erysipecosis, bacteremia, infection with unknow focus and covid-19."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive adults acutely admnitted to hospital with diagnosed sepsis on bacterial basis or on basis of covid-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elevated CRP on acute asdmission\n* elevated leukocyte count on admission\n* SOFA-score ≥ 2\n* diagnosis: bacterial sepsis\n* full age and authority\n\nExclusion Criteria:\n\n* not able to understand the protocol\n* not able to co-operate\n* diabetes mellitus of any kind'}, 'identificationModule': {'nctId': 'NCT04969159', 'briefTitle': 'The Degree, Duration and Frequency of Insulin Resistance in Non-operated Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Insulin Resistance in Septic Patients in the Acute Phase and After Discharge From Hospital', 'orgStudyIdInfo': {'id': 'insulin - sepsis'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'standard treatment in the clinical routine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200', 'city': 'Slagelse', 'country': 'Denmark', 'facility': 'Department of endocrinology, Slagelse Hospiatl', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}], 'overallOfficials': [{'name': 'Jens R Andersen, MD,MPA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plans'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Rikardt Andersen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Primary Investigator', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}