Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-30 @ 10:27 PM
Study NCT ID:
NCT01178957
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2010-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-05', 'studyFirstSubmitDate': '2010-04-21', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) secretion', 'timeFrame': '8 hours', 'description': 'Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) kinetics over a single study day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Very-Low-Density-Lipoprotein(VLDL)', 'Hyperglycemia'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '25385409', 'type': 'DERIVED', 'citation': 'Johansen RF, Sondergaard E, Sorensen LP, Nellemann B, Christiansen JS, Nielsen S. Isolated hyperglycaemia does not increase VLDL-triacylglycerol secretion in type 1 diabetic men. Diabetologia. 2015 Feb;58(2):355-62. doi: 10.1007/s00125-014-3422-6. Epub 2014 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the acute effect of hyperglycemia on Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 diabetics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Type 1 diabetes\n2. Age 18-50 years\n\nExclusion Criteria:\n\n1. Smoking\n2. Alcohol abuse\n3. Use of medications (except insulin in diabetics)'}, 'identificationModule': {'nctId': 'NCT01178957', 'briefTitle': 'Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia', 'orgStudyIdInfo': {'id': 'ES-0004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 diabetes', 'interventionNames': ['Other: Hyperglycemia']}], 'interventions': [{'name': 'Hyperglycemia', 'type': 'OTHER', 'description': 'Hyperglycemia with a blood glucose of 15 mmol/L', 'armGroupLabels': ['Type 1 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Department of Endocrinology MEA, Aarhus Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}