[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512303":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":10,"locations":41,"responsibleParty":79,"collaborators":82,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":10,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":10,"studyType":101,"phases":10,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Rio de Janeiro State University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Obese patients submitted to bariatric surgery",null,"50 patients, both females and males, aged between 18 and 60 years, who will be submitted to bariatric surgery with Roux-en-Y reconstruction reduction gastroplasty technique.\n\nPatients will be evaluated for five times: before the bariatric surgery and 3-6-12-24 months after the bariatric surgery.",[13,14,15,16,17],"Device: Holter Faros 360° EKG (Bittium Corporation)","Diagnostic Test: Beck Depression Inventory (BDI)","Diagnostic Test: Hospital Anxiety and Depression Scales - HADS","Diagnostic Test: Three Factor Eating Questionnaire-R21 - TFEQ-R21","Diagnostic Test: hort-Form Health Survey-36 itens - SF-36",[19,24,29,33,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Holter Faros 360° EKG (Bittium Corporation)","Patients will lie down on the examination table, a five-lead ECG will be attached to their chest, and they should rest for 5 minutes before starting the ECG recording. ECG data will be collected for a 15-minute period Heart Rate Variability (HRV) recording will be performed between 09:00 and 12:00 in a fixed examination room to minimize environmental factors and diurnal fluctuations in autonomic nervous system functioning.",[9],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"DIAGNOSTIC_TEST","Beck Depression Inventory (BDI)","The BDI assesses the depression severity. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"Hospital Anxiety and Depression Scales - HADS","The HADS assesses the anxiety and depression symptoms. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Three Factor Eating Questionnaire-R21 - TFEQ-R21","The TFEQ-R21assesses the quality of eating behavior. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).",[9],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"hort-Form Health Survey-36 itens - SF-36","he TFEQ-R21assesses the quality of life Divided into different areas (functional capacity, general health status, pain, vitality, social aspects, emotional aspects, and mental health). It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).",[9],[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University","RECRUITING","Rio de Janeiro","Rio de Janeiro, Brazil","20550013","Brazil","BR",{"type":51,"coordinates":52},"Point",[53,54],-43.18223,-22.90642,{"lat":54,"lon":53},[57,62,65,67,69,71,73,75,77],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},"Luiz Guilherme K De Aguiar, PhD","CONTACT","(+55+21) 23340703","lgkraemeraguiar@gmail.com",{"name":63,"role":59,"phone":60,"phoneExt":10,"email":64},"Karynne G Lisboa Lopes dos Santos, PhD","kjgolrj@gmail.com",{"name":58,"role":66,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":68,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":70,"role":68,"phone":10,"phoneExt":10,"email":10},"Daniel Sant'Anna da Silva, PhD",{"name":72,"role":68,"phone":10,"phoneExt":10,"email":10},"Eliete Bouskela, PhD",{"name":74,"role":68,"phone":10,"phoneExt":10,"email":10},"Pedro P da Silva Soares, PhD",{"name":76,"role":68,"phone":10,"phoneExt":10,"email":10},"Roberto Sirgni, Dr",{"name":78,"role":68,"phone":10,"phoneExt":10,"email":10},"Camilla Guccione, PhD",{"type":66,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Luiz Guilherme Kraemer-Aguiar, MD","Associate Professor - Endocrinology, Department of Internal Medicine - Faculty of Medical Sciences - UERJ",[83,86],{"name":84,"class":85},"Rio de Janeiro State Research Supporting Foundation (FAPERJ)","OTHER_GOV",{"name":87,"class":6},"Universidade Federal Fluminense","100512303","obesity-and-bariatric-surgery-according-to-a-biopsychosocial-perspective-100512303",false,"NCT05950698","Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.","The Assessment of Psychophysiological Markers by Analyzing the Heart Rate Variability, Blood Pressure, Anxiety and Depression, Eating Behavior, and Quality of Life Before and After Bariatric Surgery.","Inclusion Criteria:\n\n* Obese and liberated patients for the bariatric surgery.\n* informed consent.\n* Males and females between 18 and 60 years old .\n\nExclusion Criteria:\n\n* Those taking hypoglycemic medications (biguanides, sulfonylureas, glinides, acarbose, GLP-1 analogues, SGLT-2 inhibitors, DPP-IV inhibitors, and insulin) and hyperglycemic medications (corticoids, high dose thiazide diuretics, beta blockers, diazoxide and octreotide), very restrictive diets (intermittent fasting and ketogenic diet), pregnant women, history of neurological disorder, chronic pulmonary, cardiovascular, hepatic and\u002For renal diseases, in treatment for alcohol or drug abuse, smoking, severe psychiatric disorders (schizophrenia, bipolar disorder), vitamin B12 deficiency, iron-deficiency, anemia, those with neurodegenerative brain disease or cerebrovascular disease, and those who refuse to sign the informed consent form.","ALL","18 Years","60 Years",{"count":99,"type":100},50,"ESTIMATED","OBSERVATIONAL","* The main goal of this prospective longitudinal observational study is to investigate the psychophysiological indicators by analyzing HRV, blood pressure, symptoms of anxiety and depression, eating behavior and quality of life during the follow-up of the general health status of patients with obesity undergoing the bariatric surgery by Roux-en-Y reconstruction reduction gastroplasty (GRYR) technique.\n* The main question it aims to answer is: Does bariatric surgery changes the variables studied (HRV, anxiety, depression, eating behavior, quality of life)?\n* Type of study: prospective longitudinal observational study\n* Participant population: 50 patients, both females and males, aged between 18 and 60 years, will be submitted to bariatric surgery with Roux-en-Y reconstruction reduction gastroplasty technique.\n\nPatients will be evaluated for five times: before the bariatric surgery and 3-6-12-24 months after the bariatric surgery.",[104,105,106,107,108],"Obesity","Heart Rate Variability","Anxiety Disorders","Depression","Quality of Life",[104,110,111,107,108],"Heart rate variability","Anxiety","2023-07-10",{"date":114,"type":115},"2023-07-18","ACTUAL",{"date":117,"type":115},"2022-10-20",{"date":119,"type":100},"2026-10-20",{"name":5,"class":6},1]