Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT01857167
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2013-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-03-11', 'studyFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2013-05-15', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin resistance', 'timeFrame': '180 days'}]}, 'conditionsModule': {'keywords': ['omega-3 fatty acids', 'randomized controlled trial'], 'conditions': ['Type 2 Diabetes', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '22984522', 'type': 'BACKGROUND', 'citation': 'Zheng JS, Huang T, Yang J, Fu YQ, Li D. Marine N-3 polyunsaturated fatty acids are inversely associated with risk of type 2 diabetes in Asians: a systematic review and meta-analysis. PLoS One. 2012;7(9):e44525. doi: 10.1371/journal.pone.0044525. Epub 2012 Sep 11.'}, {'pmid': '27279274', 'type': 'DERIVED', 'citation': 'Zheng JS, Lin M, Fang L, Yu Y, Yuan L, Jin Y, Feng J, Wang L, Yang H, Chen W, Li D, Tang J, Cai W, Shi M, Li Z, Wang F, Li D. Effects of n-3 fatty acid supplements on glycemic traits in Chinese type 2 diabetic patients: A double-blind randomized controlled trial. Mol Nutr Food Res. 2016 Oct;60(10):2176-2184. doi: 10.1002/mnfr.201600230. Epub 2016 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'This study is to examine the change of fasting insulin, glucose, insulin sensitivity and related traits in response to the six month treatment of omega-3 fatty acids, including fish oil and flaxseed oil, in Chinese type 2 diabetic patients. Corn oil, rich in omega-6 fatty acids, will be selected as a controlled oil. The investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in Chinese type 2 diabetic patients.', 'detailedDescription': 'The insulin resistance will be estimated by a homeostatic model assessment model of insulin resistance (HOMA-IR)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fasting glucose \\> 7.0 or have diabetes medication;\n2. Male, 35-80 years; female, postmenopausal to 80 years;\n3. Agree to participant in the trial.\n\nExclusion Criteria:\n\n1. Deny to sign the informed consent;\n2. type 1 diabetes;\n3. Family history of hypertriglyceridemia or fasting triglyceride\\>4.56 mmol/L;\n4. Have severe liver disease, kidney disease or cancer;\n5. Participating in the other clinical trial within 30 days;\n6. Other diseases or conditions, for which the doctor of the patients do not agree his or her participating.'}, 'identificationModule': {'nctId': 'NCT01857167', 'briefTitle': 'Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'orgStudyIdInfo': {'id': 'DUOLI2013011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish Oil Supplementation', 'description': 'Patients will receive fish oil capsules, at a dose of 4g/day. Each 1g capsule will contain 300mg of EPA and 200mg of DHA.', 'interventionNames': ['Dietary Supplement: Fish Oil Supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Flaxseed Oil Supplementation', 'description': 'Patients will receive flaxseed oil capsule, at a dose of 4g/day. Each 1g capsule will contain 630mg of ALA', 'interventionNames': ['Dietary Supplement: Flaxseed Oil Supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Supplementation', 'description': 'Patients will receive corn oil in the capsules at the same dose as fish oil. The corn oil will appear identical in size and color to the fish oil.', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Fish Oil Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fish Oil Supplementation']}, {'name': 'Flaxseed Oil Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Flaxseed Oil Supplementation']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo Supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310058', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Duo li', 'investigatorAffiliation': 'Zhejiang University'}}}}