Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 4:26 AM
Study NCT ID:
NCT00412906
Status:
COMPLETED
Last Update Posted:
2008-05-21
First Post:
2006-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D019446', 'term': 'Endotoxemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C044101', 'term': 'endotoxin, Escherichia coli'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-20', 'studyFirstSubmitDate': '2006-12-18', 'studyFirstSubmitQcDate': '2006-12-18', 'lastUpdatePostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression evaluated by measuring mRNA via RT-PCR. Plasma cytokine content, PLasma PAI-1 content, endotoxemia score'}], 'secondaryOutcomes': [{'measure': 'Mean Arterial Pressure, heart rate, Temperature,'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Low-grade inflammation', 'insulin resistance', 'Metabolism', 'Type 2 diabetes', 'Endotoxemia', 'Fat tissue', 'Muscle tissue', 'RT-PCR'], 'conditions': ['Healthy', 'Type 2 Diabetes', 'Endotoxemia']}, 'referencesModule': {'references': [{'pmid': '21931634', 'type': 'DERIVED', 'citation': 'Andreasen AS, Kelly M, Berg RM, Moller K, Pedersen BK. Type 2 diabetes is associated with altered NF-kappaB DNA binding activity, JNK phosphorylation, and AMPK phosphorylation in skeletal muscle after LPS. PLoS One. 2011;6(9):e23999. doi: 10.1371/journal.pone.0023999. Epub 2011 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present protocol is to study gene activity in fat and muscle tissue in type 2 diabetics and healthy volunteers after injection of E. coli endotoxin.We hereby hope to gain insight in some mechanisms behind the association between inflammation and insulin resistance.', 'detailedDescription': 'Numerous studies have shown an association between low-grade inflammation and insulin-resistance in type 2 diabetics. It is also well-known that septic patients often develop insulin-resistance. The pathogenetic mechanisms behind the association between inflammation and insulin-resistance is not fully understood.\n\nIn this study we create an experimental inflammation by giving E. coli endotoxin 0,3 ng/kg iv to type 2 diabetics and healthy controls. Muscle biopsies are taken at 0, 2, 4 and 6 hours after injection, while fat biopsies are taken 0, 2, 4, 6 and 8 hours after endotoxin. mRNA for adiponectin, leptin, PPAR-gamma, PGC-1, PAI-1 and cytokines in tissue is later measured by RT-PCR.\n\nBlood samples are drawn on an hourly basis until 8 hours after endotoxin injection for common biochemical analyses including white blood cell count. Plasma is spared and later analyzed for cytokines, PAI-1 and VCAM-1/ICAM-1.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Type 2 diabetes\n\nExclusion Criteria:\n\n* Heart failure\n* Lung disease\n* Anti-coagulation treatment'}, 'identificationModule': {'nctId': 'NCT00412906', 'briefTitle': 'Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia', 'orgStudyIdInfo': {'id': 'DM2.sa.cim.rh.dk'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Escherichia Coli Endotoxin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Centre of Inflammaiton and Metabolism, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Anne Sofie Andreasen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rogshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Centre of Inflammation and Metabolism', 'oldOrganization': 'Rigshospitalet'}}}}