Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01038102
Status:
COMPLETED
Last Update Posted:
2010-07-13
First Post:
2009-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-12', 'studyFirstSubmitDate': '2009-12-21', 'studyFirstSubmitQcDate': '2009-12-21', 'lastUpdatePostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic steatosis by MRT', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance by oral glucose tolerance test', 'timeFrame': '10 weeks'}, {'measure': 'Changes in adipose tissue gene expression and lipogenic enzyme activity', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Diabetes', 'Insulin resistance', 'Fatty liver', 'NAFLD', 'Steatosis', 'Dietary fatty acids'], 'conditions': ['Obesity', 'Diabetes', 'Insulin Resistance', 'Fatty Liver']}, 'referencesModule': {'references': [{'pmid': '11914742', 'type': 'BACKGROUND', 'citation': 'Summers LK, Fielding BA, Bradshaw HA, Ilic V, Beysen C, Clark ML, Moore NR, Frayn KN. Substituting dietary saturated fat with polyunsaturated fat changes abdominal fat distribution and improves insulin sensitivity. Diabetologia. 2002 Mar;45(3):369-77. doi: 10.1007/s00125-001-0768-3.'}, {'pmid': '16179270', 'type': 'BACKGROUND', 'citation': 'Yki-Jarvinen H. Fat in the liver and insulin resistance. Ann Med. 2005;37(5):347-56. doi: 10.1080/07853890510037383.'}, {'pmid': '22492369', 'type': 'DERIVED', 'citation': 'Bjermo H, Iggman D, Kullberg J, Dahlman I, Johansson L, Persson L, Berglund J, Pulkki K, Basu S, Uusitupa M, Rudling M, Arner P, Cederholm T, Ahlstrom H, Riserus U. Effects of n-6 PUFAs compared with SFAs on liver fat, lipoproteins, and inflammation in abdominal obesity: a randomized controlled trial. Am J Clin Nutr. 2012 May;95(5):1003-12. doi: 10.3945/ajcn.111.030114. Epub 2012 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether substituting saturated fats with polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic variables in abdominally obese subjects', 'detailedDescription': 'Specific goals:\n\n1. Investigate if substituting saturated fats with polyunsaturated fats reduces steatosis and improves hepatic and/or peripheral insulin action in abdominally obese subjects with type 2 diabetes\n2. Investigate if changes of lipogenic enzymes in response to dietary fat intervention are associated with changes in hepatic/peripheral insulin sensitivity or liver fat content\n3. Investigate potential mechanism of the effects of dietary fatty acids; e.g. gene expression and lipogenic enzyme activity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* abdominal obese subjects with or without type 2 diabetes\n* sagittal abdominal diameter \\>25cm\n\nExclusion Criteria:\n\n* insulin treatment\n* history of serious cardiovascular events\n* morbid obesity\n* claustrophobia (relative criterion)'}, 'identificationModule': {'nctId': 'NCT01038102', 'acronym': 'HEPFAT', 'briefTitle': 'Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'FAS-2008-1364'}, 'secondaryIdInfos': [{'id': 'CKFUU-45521', 'type': 'OTHER_GRANT', 'domain': 'Center for clinical research Dalarna 2009'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PUFA diet', 'description': 'Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%)', 'interventionNames': ['Other: PUFA Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SFA diet', 'description': 'Diet high in saturated fat (15 E%)', 'interventionNames': ['Other: SFA diet']}], 'interventions': [{'name': 'PUFA Diet', 'type': 'OTHER', 'description': 'Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).', 'armGroupLabels': ['PUFA diet']}, {'name': 'SFA diet', 'type': 'OTHER', 'description': 'Diet high in saturated fat (15E%)', 'armGroupLabels': ['SFA diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital, Uppsala Science Park', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Ulf Risérus, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Council for Working Life and Social Research', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ulf Risérus, Ass. professor', 'oldOrganization': 'Uppsala University'}}}}