Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT04614961
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Database Concerning Patients Consulting the Obesity Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 999999}, 'targetDuration': '100 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2099-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2099-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...)', 'timeFrame': 'up to 100 years', 'description': 'The objective is to develop an Obesity Clinic registry to collect routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...) using the electronic medical record to improve the knowledge on obesity, the treatment of obesity and its outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity', 'Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'A registry of individuals that visit the Obesity Clinic of the University Hospitals of Leuven will be established. The objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes.', 'detailedDescription': 'A registry/database is constructed with data of the individuals that visit the Obesity Clinic of the University Hospitals of Leuven. Data will be obtained from the screening visits and all follow-up visits in terms of sociodemographics, treatment and treatment outcomes, disease impact, biochemistry, questionnaires, QoL, …'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with overweight, obesity or after bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Age 18 years or older\n* Subjects with overweight, obesity or after bariatric surgery'}, 'identificationModule': {'nctId': 'NCT04614961', 'briefTitle': 'Database Concerning Patients Consulting the Obesity Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Database Concerning Patients Consulting the Obesity Clinic of University Hospitals Leuven', 'orgStudyIdInfo': {'id': 'S62590'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with overweight, obesity or after bariatric surgery', 'description': 'Patients with overweight, obesity or after bariatric surgery', 'interventionNames': ['Other: Lifestyle therapy - individual', 'Other: Lifestyle therapy - group', 'Other: Medical therapy', 'Procedure: Bariatric surgery']}], 'interventions': [{'name': 'Lifestyle therapy - individual', 'type': 'OTHER', 'description': 'Individual therapy', 'armGroupLabels': ['Patients with overweight, obesity or after bariatric surgery']}, {'name': 'Lifestyle therapy - group', 'type': 'OTHER', 'description': 'Group therapy', 'armGroupLabels': ['Patients with overweight, obesity or after bariatric surgery']}, {'name': 'Medical therapy', 'type': 'OTHER', 'description': 'Medical therapy', 'armGroupLabels': ['Patients with overweight, obesity or after bariatric surgery']}, {'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'Surgical and endoscopic therapy', 'armGroupLabels': ['Patients with overweight, obesity or after bariatric surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Bart Van der Schueren, MD, PhD', 'role': 'CONTACT', 'email': 'bart.vanderschueren@uzleuven.be', 'phone': '+32 16 34 69 94'}], 'facility': 'Obesity Clinic University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Bart Van der Schueren, MD, Phd', 'role': 'CONTACT', 'email': 'bart.vanderschueren@uzleuven.be', 'phone': '+32 16 34 69 94'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}