Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-11 @ 10:50 AM
Study NCT ID:
NCT02085369
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2014-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A fasted blood sample (50 mL) will be taken before and 2h after a standardized meal.\n\nThrough epigenetic study, we will analyze the changes in DNA methylation after surgery in genes related to metabolism (at the Science for Life Laboratory (SciLifeLab) with 450K Human Meth arrays).\n\nIn addition, blood samples from these obese patients analyzed (before and after surgery) after ingestion of a predetermined test meal (for example, high protein) to explore changes in metabolites profile. Metabolites in the samples will be quantified by the SciLifeLab.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2014-01-31', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in gene expression profile (a.o. FTO, BDNF) following a standardized meal (before vs. after surgery)', 'timeFrame': '1 year', 'description': 'Gene expression profiling (whole genome analysis, with first interest in FTO and BDNF expression) to assess changes in gene expression before vs. after surgery, and to associate gene expression with weight loss after surgery'}], 'secondaryOutcomes': [{'measure': 'The effect of bariatric surgery on cognitive functioning (inhibitory control, selective attention)', 'timeFrame': 'Measures 1 y, 2 y, and 5 y after surgery.', 'description': 'No-Go go task (to assess inhibitory control) and Stroop tasks (to assess selective attention) will be measured to assess change in these cognitive functions before vs. after surgery, and to associate cognitive functioning with weight loss after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Cognitive function', 'Gene expression', 'Metabolomics', 'Obesity', 'Overweight', 'Lifestyle'], 'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': "Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (\\~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese patients with bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First bariatric surgery\n\nExclusion Criteria:\n\n* More than one surgery'}, 'identificationModule': {'nctId': 'NCT02085369', 'briefTitle': 'Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle', 'orgStudyIdInfo': {'id': 'PH2014'}, 'secondaryIdInfos': [{'id': 'PH2014', 'type': 'OTHER_GRANT', 'domain': 'Uppsala University'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Magnus Sundbom', 'role': 'CONTACT', 'email': 'magnus.sundbom@akademiska.se'}, {'name': 'Magnus Sundbom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Magnus Sundbom, MD', 'role': 'CONTACT', 'email': 'magnus.sundbom@akademiska.se'}, {'name': 'Didi Nordberg, MSc', 'role': 'CONTACT', 'email': 'didi.nordberg@gmail.com'}], 'overallOfficials': [{'name': 'Magnus Sundbom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic Hospital Uppsala'}, {'name': 'Helgi Schiöth, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uppsala University'}, {'name': 'Olga Titova, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}