Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-28 @ 3:19 PM
Study NCT ID:
NCT00829569
Status:
COMPLETED
Last Update Posted:
2011-11-04
First Post:
2009-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
n-3 Fatty Acid Infusion and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-03', 'studyFirstSubmitDate': '2009-01-26', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2011-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin sensitivity', 'timeFrame': '4 hours'}], 'secondaryOutcomes': [{'measure': 'n-3 fatty acid distribution', 'timeFrame': '4 hours'}, {'measure': 'insulin secretion', 'timeFrame': '4 hours'}, {'measure': 'energy metabolism', 'timeFrame': '4 hours'}, {'measure': 'oxidative stress', 'timeFrame': '4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intralipid', 'Omegaven', 'fish oil', 'hyperinsulinemic isoglycemic clamps', 'C-peptide glucagon test', 'indirect calorimetry', 'F2-isoprostanes'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19716144', 'type': 'RESULT', 'citation': 'Mostad IL, Bjerve KS, Basu S, Sutton P, Frayn KN, Grill V. Addition of n-3 fatty acids to a 4-hour lipid infusion does not affect insulin sensitivity, insulin secretion, or markers of oxidative stress in subjects with type 2 diabetes mellitus. Metabolism. 2009 Dec;58(12):1753-61. doi: 10.1016/j.metabol.2009.06.003. Epub 2009 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this experimental study is to investigate whether an acute lipid infusion added marine n-3 fatty acids produces effects on insulin sensitivity in subjects with type 2 diabetes, when compared with an acute lipid infusion without marine n-3 fatty acids. Furthermore other effects on intermediary metabolism are tested for.', 'detailedDescription': 'Evidence indicates that n-3 fatty acids exert several beneficial effects. However, the effects of marine n-3 fatty acids on intermediary metabolism have not been completely elucidated. In a previous study of a high intake of marine n-3 fatty acids during 9 wk we demonstrated reduced insulin sensitivity and altered proportion of carbohydrate vs. fat oxidation in subjects with type 2 diabetes. These results question the use of high doses of n-3 supplements in type 2 diabetes. It is not known to what extent such effects in type 2 diabetes can be reproduced by intravenous administration of n-3 fatty acids and/or whether short term intravenous administration has other effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes defined by clinical criteria and by absence of antibodies to glutamic acid decarboxylase.\n* HbA1c 5,5 - 8,5 %\n* Blood pressure ≤ 170 mm Hg systolic and/or ≤ 105 mm Hg diastolic\n\nExclusion Criteria:\n\n* insulin treatment\n* hypertriglyceridemia (\\> 2,1 mmol/l TG)\n* proliferative retinopathy, renal insufficiency (Se-Creatinine \\> 150 μmol/l)\n* alcoholism, congestive heart failure or other serious diseases affecting the possibility of the subject to participate\n* supplement with fish oil or marine n-3 fatty acids during the last 6 months before baseline\n* Dicumarol treatment\n* allergy to soya, fish or egg\n* pregnancy or lactation\n* smoking'}, 'identificationModule': {'nctId': 'NCT00829569', 'briefTitle': 'n-3 Fatty Acid Infusion and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '4.2003.169'}, 'secondaryIdInfos': [{'id': '03-14463', 'type': 'OTHER', 'domain': 'SLV'}, {'id': '15759', 'type': 'OTHER', 'domain': 'The Data Inspectorate'}, {'id': '03/05008', 'type': 'OTHER', 'domain': 'Biobank'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intralipid with/without Omegaven', 'description': 'Lipid infusion with/without marine n-3 fatty acids', 'interventionNames': ['Dietary Supplement: Intralipid +/- Omegaven']}], 'interventions': [{'name': 'Intralipid +/- Omegaven', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fresenius Kabi, ATC main group B05B A 02', 'Intralipid Vnr 42 79 55', 'Omegaven Vnr 55 25 54'], 'description': 'Intralipid®: the 500 ml 20% Intralipid will be infused during a hyperinsulinemic clamp. Infusion rate will increase from 50 to 100 ml/hour the first 30 min and then continue at 100 ml/hour for the next 210 min, infusion duration 240 min (4 hours) in all.\n\nIntralipid® + Omegaven®: In the 500 ml 20% Intralipid 100 ml will be replaced by 100 ml 10% Omegaven and infused during the hyperinsulinemic clamp as described for Intralipid only. Heparin (0.4 U/kg/min) will be added to both lipid emulsions.\n\nContent of marine n-3 fatty acids in 100 ml Omegaven will be 1.25-2.82 g EPA and 1.44-3.09 g DHA (seasoning variations of n-3 fatty acids in fish oil).', 'armGroupLabels': ['Intralipid with/without Omegaven']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Medicine, Division of Endocrinology, St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Valdemar Grill, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital, NTNU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'Norwegian Foundation for Health and Rehabilitation', 'class': 'OTHER'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, {'name': 'Norwegian Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}