Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-07 @ 1:09 PM
Study NCT ID:
NCT06491069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors of Depression, Anxiety and Eating Disorder After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'risk factors of depression , anxiety and rating disorder after bariatric surgery', 'timeFrame': 'baseline', 'description': 'identification of risk factors that lead to occurrence of depression and anxiety and eating disorders in patients who had bariatric surgeris'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety', 'Eating Disorders', 'Bariatric Surgery']}, 'referencesModule': {'references': [{'pmid': '30858009', 'type': 'BACKGROUND', 'citation': 'Sarwer DB, Allison KC, Wadden TA, Ashare R, Spitzer JC, McCuen-Wurst C, LaGrotte C, Williams NN, Edwards M, Tewksbury C, Wu J. Psychopathology, disordered eating, and impulsivity as predictors of outcomes of bariatric surgery. Surg Obes Relat Dis. 2019 Apr;15(4):650-655. doi: 10.1016/j.soard.2019.01.029. Epub 2019 Feb 23.'}, {'pmid': '34262156', 'type': 'BACKGROUND', 'citation': 'Brown RM, Guerrero-Hreins E, Brown WA, le Roux CW, Sumithran P. Potential gut-brain mechanisms behind adverse mental health outcomes of bariatric surgery. Nat Rev Endocrinol. 2021 Sep;17(9):549-559. doi: 10.1038/s41574-021-00520-2. Epub 2021 Jul 14.'}, {'pmid': '27913121', 'type': 'BACKGROUND', 'citation': 'Ivezaj V, Kessler EE, Lydecker JA, Barnes RD, White MA, Grilo CM. Loss-of-control eating following sleeve gastrectomy surgery. Surg Obes Relat Dis. 2017 Mar;13(3):392-398. doi: 10.1016/j.soard.2016.09.028. Epub 2016 Oct 1.'}, {'type': 'BACKGROUND', 'citation': 'undefined'}, {'pmid': '22253363', 'type': 'BACKGROUND', 'citation': 'Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'the goal of this observational study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery.\n\nparticipants will undergo psychometric tests.', 'detailedDescription': 'the aim of this study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery .\n\nand its correlation to postoperative changes in weight .\n\nAll data from the subjects will be obtained through direct interviews of postoperative patients\n\nAll subjects will be submitted to :\n\n1\\. Obtaining detailed history of\n\nAge , sex , socioeconomic level , work , educational level , marital status , functionality of the patient , special habits (smoking index , alchohol and substance abuse , feeding habits , exercise ).\n\nEvaluating the family history of obesity , psychiatric disorder , Bariatric surgery\n\nSearching for early and late complications of Bariatric surgery : Dumping syndrome , malnutrition , vomiting , hernias , redundant ght loss (by wieght skin , skin infection , vomiting .\n\nDetermining the type of surgery. degree of obesity of postoperative patients\n\nevaluated by body mass index\n\nMedical comorbidities Hypertension , diabetes , chronic kidney disease , chronic liver disease , ischemic heart disease , obstructive sleep apnea , gastric reflux , dermatological disorders\n\nPsychometric evaluation\n\nHamilton Anxiety Rating Scale\n\nHamilton Depression Rating Scale\n\nEating disorder evaluation. Eating Attitudes Test-26'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the group being investigated is patients who had obesity and underwent Bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* study sample of humans who had bariatric surgery.\n* Subjects with postoperative time of ≥ 3 months\n* Male or female aged between 18:60 years.\n\nExclusion Criteria:\n\n* Illiterate patients.\n* Patients have dementia or psychosis.\n* Age below 18 or above 60 years.\n* Patients refused to give written informed consent'}, 'identificationModule': {'nctId': 'NCT06491069', 'briefTitle': 'Risk Factors of Depression, Anxiety and Eating Disorder After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Depression, Anxiety and Eating Disorder After Bariatric Surgery', 'orgStudyIdInfo': {'id': 'Soh-Med-24-05-01MS'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Sayed Ali, MBBCh', 'role': 'CONTACT', 'email': 'ahmed_sayed_post@med.sohag.edu.eg', 'phone': '+0201010255939'}, {'name': 'Taher Abdel Raheem Sayed, professor', 'role': 'CONTACT', 'phone': '+0201153117414'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Sayed Ali', 'investigatorAffiliation': 'Sohag University'}}}}