Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-30 @ 8:25 PM
Study NCT ID:
NCT01378468
Status:
UNKNOWN
Last Update Posted:
2017-01-31
First Post:
2011-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 573}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2011-06-21', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent Stroke', 'timeFrame': 'outcome measure is assessed one year after first ischemic stroke.', 'description': 'The primary end-point of the study is a recurrent fatal or nonfatal stroke within the first 12 months after the event.'}], 'secondaryOutcomes': [{'measure': 'MI', 'timeFrame': 'one year after first ischemic stroke', 'description': 'Myocardial infarction'}, {'measure': 'death', 'timeFrame': 'one year after first ischemic stroke', 'description': 'cardiovascular death (death due to any cardiovascular or cerebrovascular event)'}, {'measure': 'TIA', 'timeFrame': 'one year after first ischemic stroke', 'description': 'transient ischemic attack'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['First Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '20446947', 'type': 'BACKGROUND', 'citation': "Ebinger M, Heuschmann PU, Jungehuelsing GJ, Werner C, Laufs U, Endres M. The Berlin 'Cream&Sugar' Study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke. Int J Stroke. 2010 Apr;5(2):126-30. doi: 10.1111/j.1747-4949.2010.00399.x."}, {'pmid': '27856951', 'type': 'DERIVED', 'citation': 'Lange KS, Nave AH, Liman TG, Grittner U, Endres M, Ebinger M. Lipoprotein(a) Levels and Recurrent Vascular Events After First Ischemic Stroke. Stroke. 2017 Jan;48(1):36-42. doi: 10.1161/STROKEAHA.116.014436. Epub 2016 Nov 17.'}, {'pmid': '26398290', 'type': 'DERIVED', 'citation': 'Batluk J, Leonards CO, Grittner U, Lange KS, Schreiber SJ, Endres M, Ebinger M. Triglycerides and carotid intima-media thickness in ischemic stroke patients. Atherosclerosis. 2015 Nov;243(1):186-91. doi: 10.1016/j.atherosclerosis.2015.09.003. Epub 2015 Sep 9.'}, {'pmid': '22935398', 'type': 'DERIVED', 'citation': 'Leonards CO, Ipsen N, Malzahn U, Fiebach JB, Endres M, Ebinger M. White matter lesion severity in mild acute ischemic stroke patients and functional outcome after 1 year. Stroke. 2012 Nov;43(11):3046-51. doi: 10.1161/STROKEAHA.111.646554. Epub 2012 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'Non-fasting triglyceride levels are thought to play a role in stroke. The investigators hypothesise that the results of a standardised oral triglyceride tolerance test in the subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of recurrent stroke within 12 months after the index event.', 'detailedDescription': "Since high postprandial triglycerides levels may be a risk factor for stroke, we use a combined oral triglyceride and glucose tolerance test in patients who had a first ischemic stroke. Follow-up after one year primarily assesses wether or not a recurrent stroke has occured. The glucose tolerance test is meant to identify patients with metabolic syndrome (and diabetes), since this condition is per se associated with increased levels of triglycerides. Potentially, the post-challenge triglyceride levels only play a role in patients without diabetes or metabolic syndrome. For further details see Ebinger et al. 'The Berlin 'Cream\\&Sugar' Study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke', IJS; 2010,5, 47-51."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the study population consists of adults with first ischemic stroke within the last three to seven days (at time of testing).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* First ischemic stroke\n* Incidence within less than 7 days\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Aphasia (if hampering informed consent)\n* Swallowing disorder\n* Pregnancy\n* Renal or hepatic failure\n* Pancreatitis\n* Cholecystolithiasis\n* Malabsorption\n* Lactose intolerance\n* Psychosis\n* Drug and/or alcohol addiction\n* Expected life expectancyr12 months\n* Inability to sign informed consent\n* Acute coronary syndrome\n* Severe heart valve disorder\n* Heart failure (NYHA III-IV)\n* Severe infectious/rheumatic disease\n* Sever metabolic disease\n* No oral glucose tolerance test in case of known diabetes'}, 'identificationModule': {'nctId': 'NCT01378468', 'briefTitle': 'Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': "The Berlin 'Cream&Sugar' Study: the Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke", 'orgStudyIdInfo': {'id': "The Berlin 'Cream&Sugar' Study"}, 'secondaryIdInfos': [{'id': '2009-010356-97', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with first ischemic stroke', 'interventionNames': ['Other: oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)']}], 'interventions': [{'name': 'oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)', 'type': 'OTHER', 'otherNames': ['cream'], 'description': 'see Ebinger et al., IJS, 2010', 'armGroupLabels': ['Patients with first ischemic stroke']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Martin Ebinger', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSB'}, {'name': 'Matthias Endres', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Saarland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Dr. phil.', 'investigatorFullName': 'Martin Ebinger', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}