Neurological Impact of Weight Reduction and Fitness Interventions

NCT06830252 | Not Yet Recruiting

• 2 other identifiers: X24-0053ACTRN12624001065583
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Overweight

Keywords

Obesity; Bariatric Surgery; Exercise; Neuroinflammation; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Markers of neuroinflammation

  Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI.

  Baseline and 12 months after surgery.

Secondary Outcomes (4)

• Cognitive function

  Baseline, 6 and 12 months after surgery.

• Anthropometric measures including height (cm), body mass (kg), body mass index (BMI; kg/m2)

  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)

  Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.

• Brain volumes

  Baseline and 12 months after surgery.

Other Outcomes (15)

• Flow-mediated dilatation (FMD; %)

  Baseline, 4.5, 6, and 12 months after surgery.

• Carotid intima-media thickness (cIMT; mm)

  Baseline and 12 months after surgery.

• Pulse wave velocity (PWV; m/s)

  Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.

Study Arms (2)

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.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Exercise.

Excercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Eligible for bariatric surgery.
• Willingness to provide informed consent and willingness to participate and comply with the study requirements

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead
• Washington University School of Medicine: collaborator
• Sydney Local Health District: collaborator
• Northern Sydney Local Health District: collaborator

Study Sites (1)

Charles Perkins Centre Clinic

Royal Prince Alfred Hospital, New South Wales, 2050, Australia

Location

Related Publications (1)

• 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.

  PMID: 31992978 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity; Neuroinflammatory Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Nervous System Diseases; Inflammation; Pathologic Processes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Coordinator

CONTACT

+61 2 8627 7413; reeja.nasir@sydney.edu.au

Coordinating Principal Investigator

CONTACT

laura.piccio@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 17, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All IPD data arising from the trial will be shared two years after publication of the main results.

Locations

AU (1)