Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-28 @ 12:48 PM
Study NCT ID:
NCT01150292
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2010-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Docosahexaenoic Acid (DHA) on Cardiovascular Disease on Diabetic Patients
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2010-06-23', 'studyFirstSubmitQcDate': '2010-06-23', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet function induced by collagen', 'timeFrame': '4 blood sampling in 10 to 13 weeks', 'description': '4 blood sampling are made during the time of study which expand from 10 weeks (washout period of 6 weeks) to 13 weeks (washout period of 9 weeks):\n\n* first at the beginning of the first period\n* second at the end of the period (2 weeks after beginning)\n* third at the beginning of the second period\n* fourth at the end of the period (2 weeks after beginning)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of cellular and plasmatic redox status', 'timeFrame': '4 blood sampling in 10 to 13 weeks', 'description': 'blood sampling are made during the time of study which expand from 10 weeks (washout period of 6 weeks) to 13 weeks (washout period of 9 weeks):\n\nfirst at the beginning of the first period second at the end of the period (2 weeks after beginning) third at the beginning of the second period fourth at the end of the period (2 weeks after beginning)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DHA supplementation', 'Type 2 diabetic patient', 'Platelet function'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '25832443', 'type': 'RESULT', 'citation': 'Vericel E, Colas R, Calzada C, Le QH, Feugier N, Cugnet C, Vidal H, Laville M, Moulin P, Lagarde M. Moderate oral supplementation with docosahexaenoic acid improves platelet function and oxidative stress in type 2 diabetic patients. Thromb Haemost. 2015 Aug;114(2):289-96. doi: 10.1160/TH14-12-1003. Epub 2015 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'Aim: to determine the effects of DHA supplementation:\n\n* on the platelet function through their aggregation and the pathway of arachidonic acid metabolism\n* on redox status on cells and plasma\n* on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400 mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out period of 6 to 9 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* woman\n* Type 2 diabetes\n* Menopausal or aged between 55 and 75 years old\n* Recent HbA1c between 6.5-10%\n* Oral anti-diabetic drugs or insulin therapy\n* Hypertension or antihypertensive drug\n\nExclusion Criteria:\n\n* Tobacco\n* Excessive drinking\n* Post-menopausal hormonal treatment\n* Treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, NSAID\n* Secondary cardiovascular prevention\n* antioxidant using\n* Fish intake \\>2 times a week\n* Anemia \\<10g/L\n* Thrombopenia \\<110g/L\n* Creatinine clearance \\<30 ml/min and/or proteinuria \\>1g/L'}, 'identificationModule': {'nctId': 'NCT01150292', 'briefTitle': 'Effects of Docosahexaenoic Acid (DHA) on Cardiovascular Disease on Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients', 'orgStudyIdInfo': {'id': '2009.555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DHA - Sunflower oil', 'description': '400 mg DHA supplementation by day for 2 weeks then placebo for 2 weeks after a wash out period of 6 to 9 weeks', 'interventionNames': ['Dietary Supplement: First period DHA']}, {'type': 'EXPERIMENTAL', 'label': 'Sunflower oil - DHA', 'description': 'Placebo during 2 weeks then 400 mg DHA supplementation by day for 2 weeks after a wash out period for 6 to 9 weeks', 'interventionNames': ['Dietary Supplement: Second period DHA']}], 'interventions': [{'name': 'First period DHA', 'type': 'DIETARY_SUPPLEMENT', 'description': '400 mg DHA supplementation by day for 2 weeks during the first study period', 'armGroupLabels': ['DHA - Sunflower oil']}, {'name': 'Second period DHA', 'type': 'DIETARY_SUPPLEMENT', 'description': '400 mg DHA supplementation by day for 2 weeks during the second study period', 'armGroupLabels': ['Sunflower oil - DHA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'overallOfficials': [{'name': 'Martine LAVILLE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}