Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT02379702
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2014-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome Prevalence Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C539689', 'term': 'ANAPC16 protein, human'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1659}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-02', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comorbidities and changes in general health', 'timeFrame': '10 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Following the first study conducted to investigate the prevalence of metabolic syndrome and its components in Turkey, it was aimed to demonstrate the change in general health condition of available patients after the period of time lapsed. This study will provide important information on the social and economic dimensions of metabolic syndrome and will contribute to development of preventive programs.', 'detailedDescription': 'In the first METSAR-I study conducted in 2003, metabolic syndrome screening was made by two different team. Participants were visited at their addresses and informed about the research study and gave written consent. They were invited on an empty stomach for hospital visit on the day after. Pre-trained nurses completed the forms of patients during that second visit. After 11 years, a questionnaire by telephone survey will be applied to patients who participated in the METSAR-II study. The main goal is to determine the changes of metabolic syndrome population during that period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The previous study included 4.264 patients from 47 cities and we are going to try to get in contact all those patients. Data obtained from available patients will be analysed and the change trend will be evaluated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers who participated in the METSAR-I study in 2003\n* Patients who accepted to participate will be included the second follow up phase.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT02379702', 'briefTitle': 'Metabolic Syndrome Prevalence Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abdi Ibrahim Ilac San. ve Tic A.S.'}, 'officialTitle': 'Turkey Metabolic Syndrome Prevalence Study - METSAR II', 'orgStudyIdInfo': {'id': 'METSAR-II'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Metabolic Syndrome', 'type': 'OTHER', 'description': 'This study will provide important information on the social and economic dimensions of metabolic syndrome'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Yuksek Ihtisas Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Cerrahpasa University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medeniyet University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Prof. Dr. Omer Kozan', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Omer Kozan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dokuz Eylul University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abdi Ibrahim Ilac San. ve Tic A.S.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}