Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-11 @ 7:44 PM
Study NCT ID:
NCT02720133
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2014-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-17', 'studyFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'clopidogrel and aspirin related complications', 'timeFrame': '5 years'}], 'primaryOutcomes': [{'measure': 'all cause clinical complications', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'evidence of acute coronary complications', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ramadan fasting', 'variation of biochemical parameters', 'variation of hematological parameters', 'verify now assay'], 'conditions': ['Cardiovascular Risk Factors', 'Fasting']}, 'referencesModule': {'references': [{'pmid': '23997915', 'type': 'RESULT', 'citation': 'Attarzadeh Hosseini SR, Hejazi K. The effects of ramadan fasting and physical activity on blood hematological-biochemical parameters. Iran J Basic Med Sci. 2013 Jul;16(7):845-9.'}, {'pmid': '29529091', 'type': 'DERIVED', 'citation': 'Bouida W, Beltaief K, Baccouche H, Sassi M, Dridi Z, Trabelsi I, Laaouiti K, Chakroun T, Hellara I, Boukef R, Sakly N, Hassine M, Added F, Razgallah R, Najjar F, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on aspirin resistance in type 2 diabetic patients. PLoS One. 2018 Mar 12;13(3):e0192590. doi: 10.1371/journal.pone.0192590. eCollection 2018.'}, {'pmid': '28588426', 'type': 'DERIVED', 'citation': 'Bouida W, Baccouche H, Sassi M, Dridi Z, Chakroun T, Hellara I, Boukef R, Hassine M, Added F, Razgallah R, Khochtali I, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on platelet reactivity in diabetic patients treated with clopidogrel. Thromb J. 2017 Jun 2;15:15. doi: 10.1186/s12959-017-0138-0. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/23997915', 'label': 'The effects of ramadan fasting and physical activity on glycemic control, lipid metabolism, and the effects clopidogrel and aspirin activityameters.'}]}, 'descriptionModule': {'briefSummary': 'Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.', 'detailedDescription': 'This is a prospective observational study, including patients with cardiovascular risk factors and doing the fast of Ramadan with assessment before, during and after the month of Ramadan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stable patients with cardiovascular risk factors who fast during Ramadan', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cardiovascular risk factors in stable conditions\n* Ramadan fasting\n\nExclusion Criteria:\n\n* Impossibility, contraindication or interruption of fasting'}, 'identificationModule': {'nctId': 'NCT02720133', 'briefTitle': 'Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors', 'orgStudyIdInfo': {'id': 'GR2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with cardiovascular risk factors who fast Ramadan', 'description': 'Stable clinical and biochemical parameters before Ramadan fasting', 'interventionNames': ['Biological: biochemical parameters']}], 'interventions': [{'name': 'biochemical parameters', 'type': 'BIOLOGICAL', 'otherNames': ['hematological parameters assay', 'verify now assay'], 'description': 'patients will be collected for analysis of blood standard examinations such as blood glucose, electrolytes (potassium, sodium, magnesium calcium), renal function and also the blood count, platelet aggregation.\n\nAll these tests should be practice before, during and after Ramadan fasting for comparison.', 'armGroupLabels': ['Patients with cardiovascular risk factors who fast Ramadan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Non-US/Canada', 'country': 'Tunisia', 'facility': 'Emergency Departement', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Semir Nouira, Pr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Of Monastir Tunisia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of departement', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}