Neurological Impact of Weight Reduction and Fitness Interventions

NCT ID: NCT06830252

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Excercise

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Exercise.

Interventions

Exercise

Exercise.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Sydney Local Health District

OTHER_GOV

Sponsor Role: collaborator

Northern Sydney Local Health District

UNKNOWN

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Charles Perkins Centre Clinic

Royal Prince Alfred Hospital, New South Wales, Australia

Countries

Australia

Central Contacts

Study Coordinator

Role: CONTACT

reeja.nasir@sydney.edu.au

+61 2 8627 7413

Coordinating Principal Investigator

Role: CONTACT

laura.piccio@sydney.edu.au

Facility Contacts

Study Coordinator

Role: primary

reeja.nasir@sydney.edu.au

+61 2 8627 7413

Principal Investigator

Role: backup

luigi.fontana@sydney.edu.au

References

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.

Reference Type: BACKGROUND

PMID: 31992978 (View on PubMed)

Other Identifiers

ACTRN12624001065583

Identifier Type: REGISTRY

Identifier Source: secondary_id

X24-0053

Identifier Type: -

Identifier Source: org_study_id