Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-03 @ 3:04 PM
Study NCT ID:
NCT05642533
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2022-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obesity and Cardiovascular Diseases, Cross-sectional Study in Saudi Arabia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1061}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of people with obesity without a history of Type 2 diabetes (T2D) who have Cardiovascular disease (CVD)s (pre-existing or newlydiagnosed)', 'timeFrame': 'At time of patient enrollment/cross-sectional routine visit (DAY 1)', 'description': 'Percentage (and 95% confidence interval \\[CI\\])'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity and Cardiovascular Risk']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to collect information on participants body weight, blood sugar levels, heart related diseases and lifestyle. The collected information will help estimate the prevalence of participants disease.\n\nThis study will take about 6 months. However, participants involvement in the study will not extend beyond their routine visit and will thus require a maximum of 1 day.\n\nIf participants choose to take part, they will be asked to give information about their health in routine clinical visit. Participants will be asked to complete a questionnaire about their lifestyle. Participants will complete this questionnaire during their normally scheduled visit with their doctor. Participants will continue their normal way of life and will not get any medication other than those prescribed to them by their doctor.\n\nParticipants will have no direct benefit from participation in this study and there are no risks involved.\n\nParticipants decide voluntarily whether they want to participate in this study or not. Participants' decision will not affect their medical care and they do not have to justify their decision.\n\nParticipants are free to leave the study at any time and without giving reasons. This does not affect their current or future treatment. The data collected up to that point are still being evaluated.\n\nThere is no additional cost to participants for being in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adults with obesity, either without a history of T2D (Cohort 1) or with a history of T2D (Cohort 2).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed consent obtained before any study related activities (study related activities are any procedure-related to recording of data according to the protocol).\n2. Diagnosed with obesity (BMI higher than or equal to 30 for all ethnic groups except Asian; BMI higher than or equal to 27.5 for patients of Asian ethnicity).\n3. Diagnosed with T2D for patients in Cohort 2.\n4. Male or female, aged between 18 and 75 years at the time of signing informed consent\n\nExclusion Criteria:\n\n1. Participation in an interventional clinical trial during the study period.\n2. Diagnosed with T2D for patients in Cohort 1.\n3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT05642533', 'acronym': 'OCCURS', 'briefTitle': 'Obesity and Cardiovascular Diseases, Cross-sectional Study in Saudi Arabia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Obesity and Cardiovascular Diseases, Cross-sectional Study in Saudi Arabia', 'orgStudyIdInfo': {'id': 'DAS-7510'}, 'secondaryIdInfos': [{'id': 'U1111-1279-3716', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Without a history of Type 2 diabetes', 'description': 'Adults with obesity', 'interventionNames': ['Other: No treatment given']}, {'label': 'With a history of Type 2 diabetes', 'description': 'Adults with obesity', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'No treatment given', 'armGroupLabels': ['With a history of Type 2 diabetes', 'Without a history of Type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36428', 'city': 'Al Ahsa', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz Hospital-Al Ahsa-National Guard'}, {'zip': '34313', 'city': 'Dammam', 'country': 'Saudi Arabia', 'facility': 'King Fahad Military Medical Complex in Dhahran', 'geoPoint': {'lat': 26.43442, 'lon': 50.10326}}, {'zip': '23323', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Dr Soliman Fakeeh Hospital', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '80215', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Abdul Aziz University Hospital - Jeddah', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '12372', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Khaled University Hospital,King Saud Univ. Med. City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': '"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}