[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579896":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":81,"studyPopulation":75,"armGroups":82,"interventions":93,"overallOfficials":75,"centralContacts":99,"locations":108,"responsibleParty":123,"collaborators":125,"id":134,"slug":75,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":135,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":75,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":158,"whyStopped":75,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"University of Sydney","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Markers of neuroinflammation","Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI.","Baseline and 12 months after surgery.",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Cognitive function","This will be a composite outcome. Validated questionnaires such as Stroop Test.","Baseline, 6 and 12 months after surgery.",{"measure":19,"description":20,"timeFrame":21},"Anthropometric measures including height (cm), body mass (kg), body mass index (BMI; kg\u002Fm2)","This will be assessed as a composite outcome. Assessed via a wall-mounted stadiometer and digital scales.","Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.",{"measure":23,"description":24,"timeFrame":21},"Metabolic biomarkers (e.g., LDL Cholesterol), peripheral blood cell profiling (e.g., WBC), and immune biomarkers (e.g., IL-6)","Venous blood collection, analysed via ELISA.",{"measure":26,"description":27,"timeFrame":12},"Brain volumes","Between groups and within groups at 12 months after randomisation with respect to baseline. Assessed via T1 and T2 MRI.",[29,33,35,38,40,42,45,48,50,53,55,58,62,66,69],{"measure":30,"description":31,"timeFrame":32},"Flow-mediated dilatation (FMD; %)","Assessed via high-resolution ultrasound and semi-automated edge detection software.","Baseline, 4.5, 6, and 12 months after surgery.",{"measure":34,"description":31,"timeFrame":12},"Carotid intima-media thickness (cIMT; mm)",{"measure":36,"description":37,"timeFrame":21},"Pulse wave velocity (PWV; m\u002Fs)","Assessed via the SphygmoCor XCEL System.",{"measure":39,"description":37,"timeFrame":21},"Augmentation Index (AI)",{"measure":41,"description":37,"timeFrame":21},"Peripheral and Central blood pressures (mmHg)",{"measure":43,"description":44,"timeFrame":21},"Heart rate variability (HRV; ms2)","This will be assessed as a composite outcome. Assessed via the Human Non-Invasive Blood Pressure System.",{"measure":46,"description":47,"timeFrame":12},"Bone mineral density (g\u002Fcm2) of the hip","Assessed via the Hologic Discovery W Dual Energy X-Ray (DEXA) Absorptiometry Scanner.",{"measure":49,"description":47,"timeFrame":12},"Whole body fat-free mass (%)",{"measure":51,"description":52,"timeFrame":12},"Total sleep time (mins)","Assessed via the Nox-T3+ Device.",{"measure":54,"description":52,"timeFrame":12},"Sleep efficiency (%)",{"measure":56,"description":57,"timeFrame":12},"Sleep-behaviours","Assessed via validated questionnaires (STOP BANG, SAGIC, and Epworth Sleepiness Scale).",{"measure":59,"description":60,"timeFrame":61},"Composite metabolic control","Glucose and insulin response to oral glucose tolerance test (75g) at 0, 30, 60, 120 minutes.","Baseline.",{"measure":63,"description":64,"timeFrame":65},"Diet quantity and quality","This will be assessed as a composite outcome. This will be assessed via a 3-day Food Diary, analysed with FoodWorks.","Baseline, 6 and12 months after surgery.",{"measure":67,"description":68,"timeFrame":12},"Changes in health-related quality of life","The Medical Outcomes Study Short-Form 36 Health Status Survey (SF-36). The scores will be standardised according to the normative values for the Australian context.",{"measure":70,"description":71,"timeFrame":12},"Changes in social-related quality of life","The Australian version of the Assessment of Quality of Life (AQoL).",{"allocation":73,"interventionModel":74,"interventionModelDescription":75,"primaryPurpose":76,"observationalModel":75,"timePerspective":75,"maskingInfo":77},"RANDOMIZED","PARALLEL",null,"BASIC_SCIENCE",{"masking":78,"maskingDescription":75,"whoMasked":79},"SINGLE",[80],"OUTCOMES_ASSESSOR","This randomised controlled trial aims to evaluate the effects of marked weight loss, via bariatric surgery, combined with a personalised exercise intervention on markers of brain inflammation. This study will allow the investigators to explore the link between excessive adiposity-induced systemic chronic inflammation, metabolic abnormalities, and neuroinflammation. The investigators hypothesise that bariatric surgery, i.e., marked weight loss, and exercise will result in attenuated neuroinflammation (as measured by neuroimaging), improvements in cognitive function, improvements in immune-inflammatory markers, and improvements in cardiometabolic biomarkers at 12 months compared to control.\n\nThis study is a parallel group, randomised controlled trial. A 1:1 allocation ratio will be applied to either the intervention group (bariatric surgery and usual care with exercise) or control group (bariatric surgery and usual care). Participants in both arms will be followed over a period of 12 months after surgery. A comprehensive set of evaluations will be performed prior to the surgery, with follow-up in-person evaluations at 6 weeks and 3, 4.5, 6, and 12 months.\n\nThe primary objective is to evaluate the effect of bariatric surgery and exercise on neuroinflammation compared to control at 12-months. This will be assessed via a novel neuroimaging technique. Secondary and exploratory objectives are to evaluate the effect of bariatric surgery and exercise on brain structure, cognition, immune-inflammatory markers, cardiometabolic markers, psychosocial factors, diet, and physical functioning compared to control. The investigators would also like to explore within-group differences for all the above from baseline to 12-months.",[83,87],{"label":84,"type":85,"description":86,"interventionNames":75},"Usual Care","NO_INTERVENTION","Control participants will undergo bariatric surgery and receive usual clinical care which includes continued communication and reviews from their health team. Control participants will also be given a Fitbit device and have once a month phone follow-up with the study team and Accredited Exercise Physiologist (AEP). The discussion will be based on current literature on exercise for bariatric surgery patients and will not be personalised.",{"label":88,"type":89,"description":90,"interventionNames":91},"Excercise","EXPERIMENTAL","Eligible participants will undergo either gastric bypass or gastric sleeve surgery. Between weeks 6 and 18, participants will attend a supervised physical activity programme. This programme will be individualised per each participant's baseline activity and injuries. Participants will attend 2-3 1-hour appointments per week with their Accredited Exercise Physiologist (AEP), The supervised sessions will be delivered either in an individual setting or in a group of up to three, as needed. Following the supervised period, participants will be given an individualised home based programme and will be monitored via the Fitbit and regular phone follow-up till 12-months post-surgery. If participants are not meeting exercising as per their programme, they will be contacted using the escalating methods of email, text message or phone calls and will be invited to attend in-person supervised sessions.",[92],"Behavioral: Exercise",[94],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":75},"BEHAVIORAL","Exercise","Exercise.",[88],[100,105],{"name":101,"role":102,"phone":103,"phoneExt":75,"email":104},"Study Coordinator","CONTACT","+61 2 8627 7413","reeja.nasir@sydney.edu.au",{"name":106,"role":102,"phone":75,"phoneExt":75,"email":107},"Coordinating Principal Investigator","laura.piccio@sydney.edu.au",[109],{"facility":110,"status":75,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":75,"geoPoint":75,"contacts":116},"Charles Perkins Centre Clinic","Royal Prince Alfred Hospital","New South Wales","2050","Australia","AU",[117,118,121],{"name":101,"role":102,"phone":103,"phoneExt":75,"email":104},{"name":119,"role":102,"phone":75,"phoneExt":75,"email":120},"Principal Investigator","luigi.fontana@sydney.edu.au",{"name":101,"role":122,"phone":75,"phoneExt":75,"email":75},"SUB_INVESTIGATOR",{"type":124,"investigatorFullName":75,"investigatorTitle":75,"investigatorAffiliation":75,"oldNameTitle":75,"oldOrganization":75},"SPONSOR",[126,128,131],{"name":127,"class":6},"Washington University School of Medicine",{"name":129,"class":130},"Sydney Local Health District","OTHER_GOV",{"name":132,"class":133},"Northern Sydney Local Health District","UNKNOWN","100579896",false,"NCT06830252","Neurological Impact of Weight Reduction and Fitness Interventions","A Randomised Controlled Trial To Evaluate the Effects of Marked Weight Loss Combined With Exercise Training on Metabolic, Immunological, and Imaging Biomarkers of Systemic and Brain Inflammation in Participants Undergoing Bariatric Surgery","NeuroFit","Inclusion Criteria:\n\n* 18-80 years of age.\n* Eligible for bariatric surgery.\n* Willingness to provide informed consent and willingness to participate and comply with the study requirements\n\nExclusion Criteria:\n\n* Unable to undertake MRI due to size restrictions i.e., shoulder width more than 70 cm.\n* History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardio- vascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic, muscular, and joint disorders, or cancer that, in the opinion of the investigator, would make the candidate ineligible for the study. For example, significant joint pain could interfere with adherence to the exercise program.\n* Have objectively assessed cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA) i.e., total score less than 26.\n* Non-MRI-compatible implanted devices or implants.\n* Inability to exercise via supine ergometer.\n* Claustrophobia.\n* Psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder).\n* Breastfeeding or pregnant women, or those intending to become pregnant before the scheduled end of the intervention.\n* Unwilling to be assigned at random to the exercise or control intervention.\n* Unwilling or unable to adhere to the rigors of the exercise intervention or evaluation schedule over the entire one-year period.\n* Concurrent participation in any other interventional study.","ALL","18 Years","80 Years",{"count":145,"type":146},50,"ESTIMATED","INTERVENTIONAL",[149],"NA","This study will test how significant weight loss through bariatric surgery, combined with a personalised exercise program, affects brain inflammation. Th investigators want to understand the connection between obesity-related body inflammation, metabolic issues, and brain inflammation and function.",[152],"Obesity and Overweight",[154,155,96,156,157],"Obesity","Bariatric Surgery","Neuroinflammation","Cognitive Function","NOT_YET_RECRUITING","2025-02-11",{"date":161,"type":162},"2025-02-17","ACTUAL",{"date":164,"type":146},"2025-02",{"date":166,"type":146},"2027-12",{"name":5,"class":6},1]