An interventional study of Exercise in Obesity and Overweight, sponsored by University of Sydney. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by University of Sydney · Not applicable, Interventional, and Basic science
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.
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.
This 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.
The 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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 50 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →University of Sydney is the lead sponsor of 94 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
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.
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.
Behavioral: Exercise
Exercise.
Markers of neuroinflammation
Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI.
Time frame: Baseline and 12 months after surgery.
Cognitive function
This will be a composite outcome. Validated questionnaires such as Stroop Test.
Time frame: Baseline, 6 and 12 months after surgery.
Anthropometric measures including height (cm), body mass (kg), body mass index (BMI; kg/m2)
This will be assessed as a composite outcome. Assessed via a wall-mounted stadiometer and digital scales.
Time frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
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.
Time frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Brain volumes
Between groups and within groups at 12 months after randomisation with respect to baseline. Assessed via T1 and T2 MRI.
Time frame: Baseline and 12 months after surgery.
Flow-mediated dilatation (FMD; %)
Assessed via high-resolution ultrasound and semi-automated edge detection software.
Time frame: Baseline, 4.5, 6, and 12 months after surgery.
Carotid intima-media thickness (cIMT; mm)
Assessed via high-resolution ultrasound and semi-automated edge detection software.
Time frame: Baseline and 12 months after surgery.
Pulse wave velocity (PWV; m/s)
Assessed via the SphygmoCor XCEL System.
Time frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Augmentation Index (AI)
Assessed via the SphygmoCor XCEL System.
Time frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Peripheral and Central blood pressures (mmHg)
Assessed via the SphygmoCor XCEL System.
Time frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Heart rate variability (HRV; ms2)
This will be assessed as a composite outcome. Assessed via the Human Non-Invasive Blood Pressure System.
Time frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Bone mineral density (g/cm2) of the hip
Assessed via the Hologic Discovery W Dual Energy X-Ray (DEXA) Absorptiometry Scanner.
Time frame: Baseline and 12 months after surgery.
Whole body fat-free mass (%)
Assessed via the Hologic Discovery W Dual Energy X-Ray (DEXA) Absorptiometry Scanner.
Time frame: Baseline and 12 months after surgery.
Total sleep time (mins)
Assessed via the Nox-T3+ Device.
Time frame: Baseline and 12 months after surgery.
Sleep efficiency (%)
Assessed via the Nox-T3+ Device.
Time frame: Baseline and 12 months after surgery.
Sleep-behaviours
Assessed via validated questionnaires (STOP BANG, SAGIC, and Epworth Sleepiness Scale).
Time frame: Baseline and 12 months after surgery.
Composite metabolic control
Glucose and insulin response to oral glucose tolerance test (75g) at 0, 30, 60, 120 minutes.
Time frame: Baseline.
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.
Time frame: Baseline, 6 and12 months after surgery.
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.
Time frame: Baseline and 12 months after surgery.
Changes in social-related quality of life
The Australian version of the Assessment of Quality of Life (AQoL).
Time frame: Baseline and 12 months after surgery.
Plan to share: Yes — The data collected for the study, including individual patient data and a data dictionary that defines each field in the data set, will be made available as de-identified participant data to researchers who propose to use the data for individual patient data meta-analysis. Data will be shared following approval of the proposal by the corresponding author and a signed data access agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: All IPD data arising from the trial will be shared two years after publication of the main results.
Start is estimated for Feb 2025; primary completion for Dec 2027, 34 months later.
Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 34 months is above that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University of Sydney