Obesity and OverweightNeuroFitNCT06830252
Neurological Impact of Weight Reduction and Fitness Interventions
A study testing Exercise in people with Obesity and Overweight, run by University of Sydney at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age.
- Eligible for bariatric surgery.
- Willingness to provide informed consent and willingness to participate and comply with the study requirements
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Coordinating Principal Investigator contact
Australia1 site
Charles Perkins Centre Clinic
Royal Prince Alfred Hospital, New South Wales, 2050
Study Coordinator, +61 2 8627 7413, reeja.nasir@sydney.edu.au
Principal Investigator, luigi.fontana@sydney.edu.au
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Obesity and Overweight
- Being tested
- Exercise
- Keywords
- Obesity, Bariatric Surgery, Exercise, Neuroinflammation, Cognitive Function
- Medical subject headings
- Obesity, Overweight, Motor Activity, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
| 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of neuroinflammation
Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI.
Measured: Baseline and 12 months after surgery.
Secondary outcomes (4)
Cognitive function
This will be a composite outcome. Validated questionnaires such as Stroop Test.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Sydney Local Health District, Northern Sydney Local Health District
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830252
- Sponsor's protocol ID
- X24-0053
- Other IDs
- ACTRN12624001065583
- Acronym
- NeuroFit
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Samara A, Murphy T, Strain J, Rutlin J, Sun P, Neyman O, Sreevalsan N, Shimony JS, Ances BM, Song SK, Hershey T, Eisenstein SA. Neuroinflammation and White Matter Alterations in Obesity Assessed by Diffusion Basis Spectrum Imaging. Front Hum Neurosci. 2020 Jan 14;13:464. doi: 10.3389/fnhum.2019.00464. eCollection 2019.
PubMed 31992978
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06830252
- Acronym / sponsor ID
- NeuroFit / X24-0053
- Conditions
- Obesity and Overweight
- Keywords
- Obesity, Bariatric Surgery, Exercise, Neuroinflammation, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Sydney Local Health District, Northern Sydney Local Health District
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Excercise | Experimental | Behavioral: ExerciseEligible 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 years of age.
- Eligible for bariatric surgery.
- Willingness to provide informed consent and willingness to participate and comply with the study requirements
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise. | Behavioural | Excercise |
Primary outcome
Markers of neuroinflammation
Time frame: Baseline and 12 months after surgery.
Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI.
4 secondary outcomes
Cognitive function
Time frame: Baseline, 6 and 12 months after surgery.
Anthropometric measures including height (cm), body mass (kg), body mass index (BMI; kg/m2)
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)
Time frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Brain volumes
Time frame: Baseline and 12 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 31992978Samara A, Murphy T, Strain J, Rutlin J, Sun P, Neyman O, Sreevalsan N, Shimony JS, Ances BM, Song SK, Hershey T, Eisenstein SA. Neuroinflammation and White Matter Alterations in Obesity Assessed by Diffusion Basis Spectrum Imaging. Front Hum Neurosci. 2020 Jan 14;13:464. doi: 10.3389/fnhum.2019.00464. eCollection 2019.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Coordinating Principal Investigator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity and Overweight, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (+61 2 8627 7413, reeja.nasir@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of neuroinflammation (time frame: Baseline and 12 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.