Neurological Impact of Weight Reduction and Fitness Interventions
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 18-80 years of age.
- Eligible for bariatric surgery.
- Willingness to provide informed consent and willingness to participate and comply with the study requirements
Exclusion criteria
- Unable to undertake MRI due to size restrictions i.e., shoulder width more than 70 cm.
- 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.
- Have objectively assessed cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA) i.e., total score less than 26.
- Non-MRI-compatible implanted devices or implants.
- Inability to exercise via supine ergometer.
- Claustrophobia.
- Psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder).
- Breastfeeding or pregnant women, or those intending to become pregnant before the scheduled end of the intervention.
- Unwilling to be assigned at random to the exercise or control intervention.
- Unwilling or unable to adhere to the rigors of the exercise intervention or evaluation schedule over the entire one-year period.
- Concurrent participation in any other interventional study.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
BASIC_SCIENCE
Phase
- NA
Study ID
NCT06830252
Intervention or treatment
BEHAVIORAL: Exercise
Conditions
- Obesity and Overweight
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Charles Perkins Centre Clinic
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Charles Perkins Centre Clinic
Royal Prince Alfred Hospital, New South Wales, Australia
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Who is running the clinical trial?
University of Sydney
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
NO_INTERVENTION: Usual Care
| |
EXPERIMENTAL: Excercise
| Behavioral: Exercise |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Markers of neuroinflammation | Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI. | Baseline and 12 months after surgery. |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | This will be a composite outcome. Validated questionnaires such as Stroop Test. | 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. | 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. | 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. | Baseline and 12 months after surgery. |
References
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