Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00780520
Status:
COMPLETED
Last Update Posted:
2008-10-27
First Post:
2008-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Glutamine on Systemic Inflammation During Human Experimental Endotoxemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-24', 'studyFirstSubmitDate': '2008-10-24', 'studyFirstSubmitQcDate': '2008-10-24', 'lastUpdatePostDateStruct': {'date': '2008-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma-levels of cytokines'}], 'secondaryOutcomes': [{'measure': 'Heat shock protein -70 production from BMNCs'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['glutamine inflammation HSP70 sepsis'], 'conditions': ['Sepsis', 'Systemic Inflammation']}, 'referencesModule': {'references': [{'pmid': '19173710', 'type': 'DERIVED', 'citation': 'Andreasen AS, Pedersen-Skovsgaard T, Mortensen OH, van Hall G, Moseley PL, Pedersen BK. The effect of glutamine infusion on the inflammatory response and HSP70 during human experimental endotoxaemia. Crit Care. 2009;13(1):R7. doi: 10.1186/cc7696. Epub 2009 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'Glutamine levels decrease during severe sepsis; this may be associated with increased mortality. The investigators tested the effects of glutamine supplementation on systemic inflammation in a human sepsis model.\n\nThe investigators found that glutamine levels drops significantly during experimentally induced systemic inflammation. However, glutamine did not affect the degree of inflammation.', 'detailedDescription': 'Glutamine levels have been shown to decrease substantially with severe sepsis and this has been connected with increased mortality. Therefore, in the present study, we infused either saline or Alanine-glutamine during an endotoxin challenge and measured parameters related to an immune response, i.e. plasma cytokines and Heat Shock Protein (HSP)-70.\n\nMaterials and Methods This was a double blind, randomised, placebo-controlled crossover trial in eight healthy young men. The study was performed in random order on two separate days, with a four-week washout period between days. Subjects received an infusion of Alanine-glutamine ( Dipeptiven) at a rate of 0.025 g / (kg BW \\* h) for 10 hrs or saline. After two hours of infusion subjects received an intravenous bolus of E. coli endotoxin (0.3 ng/kg). Blood samples were collected hourly for the following eight hours. HSP-70 protein content in isolated Blood Mononuclear Cells (BMNCs) was measured by western blotting.\n\nResults and Discussion Plasma glutamine was significantly increased during infusion with alanine-glutamine infusion. En-dotoxin caused a reduction in plasma-glutamine during saline infusion as well as during Alanine-glutamine infusion. A significant effect of endotoxin was found on leukocyte subpopulations, tumor necrosis factor-a, interleukin-6, the expression of HSP-70 in BMNCs, temperature, and heart rate. However, no differences were detected between treatments with regard to the effect of endotoxin on any of these parameters.\n\nConclusion Endotoxemia reduces plasma glutamine independently of parenteral infusion of alanine-glutamine. Glutamine does not alter the response of leukocytes, leukocyte subpopulations, IL-6, or TNF-α, or the expression of HSP-70 in BMNCs to endotoxemia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy young males\n\nExclusion Criteria:\n\n* Any kind of acute or chronic diseases'}, 'identificationModule': {'nctId': 'NCT00780520', 'briefTitle': 'The Effect of Glutamine on Systemic Inflammation During Human Experimental Endotoxemia', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Effect of Glutamine Infusion on the Inflammatory Response and HSP-70 in BMNCs During Human Experimental', 'orgStudyIdInfo': {'id': 'H-KF-01-144/98'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Dietary Supplement: alanine-glutamine infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Dietary Supplement: alanine-glutamine infusion']}], 'interventions': [{'name': 'alanine-glutamine infusion', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Centre of Inflammation and Metabolism, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}