Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00760760
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2008-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
n-3 Polyunsaturated Fatty Acids in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C405603', 'term': 'Omacor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2008-09-25', 'studyFirstSubmitQcDate': '2008-09-25', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adipose tissue inflammation', 'timeFrame': 'Eight weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Metabolic control', 'timeFrame': 'Eight weeks of treatment'}, {'measure': 'Dependence of effects on Pparg polymorphisms', 'timeFrame': 'Eight weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adipose Tissue Inflammation', 'Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '23372745', 'type': 'DERIVED', 'citation': 'Itariu BK, Zeyda M, Leitner L, Marculescu R, Stulnig TM. Treatment with n-3 polyunsaturated fatty acids overcomes the inverse association of vitamin D deficiency with inflammation in severely obese patients: a randomized controlled trial. PLoS One. 2013;8(1):e54634. doi: 10.1371/journal.pone.0054634. Epub 2013 Jan 25.'}, {'pmid': '23034965', 'type': 'DERIVED', 'citation': 'Itariu BK, Zeyda M, Hochbrugger EE, Neuhofer A, Prager G, Schindler K, Bohdjalian A, Mascher D, Vangala S, Schranz M, Krebs M, Bischof MG, Stulnig TM. Long-chain n-3 PUFAs reduce adipose tissue and systemic inflammation in severely obese nondiabetic patients: a randomized controlled trial. Am J Clin Nutr. 2012 Nov;96(5):1137-49. doi: 10.3945/ajcn.112.037432. Epub 2012 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-diabetic morbidly obese patients (BMI \\> 40 kg/m2) supposed to undergo bariatric surgery\n* Age 20-65 yrs\n\nExclusion Criteria:\n\n* Acute illness within the last two week\n* Known diabetes mellitus or current anti-diabetic medication\n* Acquired immunodeficiency (HIV infection)\n* Hepatitis or other significant liver disease\n* Severe or untreated cardiovascular, renal, pulmonary disease\n* Untreated or inadequately treated clinically significant thyroid disease\n* Anemia\n* Active malignant disease\n* Inborn or acquired bleeding disorder including warfarin treatment\n* Pregnancy or breast feeding\n* Drug intolerability that prohibits the use of the study drug'}, 'identificationModule': {'nctId': 'NCT00760760', 'acronym': 'PUFA-ATI', 'briefTitle': 'n-3 Polyunsaturated Fatty Acids in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients', 'orgStudyIdInfo': {'id': 'PUFA-ATI1'}, 'secondaryIdInfos': [{'id': 'OeNB12735'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'n-3 PUFA', 'interventionNames': ['Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: control']}], 'interventions': [{'name': 'reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)', 'type': 'DRUG', 'otherNames': ['Omacor®'], 'description': '4g daily, 8 weeks', 'armGroupLabels': ['n-3 PUFA']}, {'name': 'control', 'type': 'DRUG', 'description': 'equivalent amount of fat as butter', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Thomas M Stulnig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Bank of Austria', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thomas M Stulnig', 'investigatorAffiliation': 'Medical University of Vienna'}}}}