Neurological Impact of Weight Reduction and Fitness Interventions (NeuroFit)

February 11, 2025 updated by: University of Sydney

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: Exercise
Exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of neuroinflammation
Time Frame: Baseline and 12 months after surgery.
Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI.
Baseline and 12 months after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Baseline, 6 and 12 months after surgery.
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)
Time Frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
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)
Time Frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Venous blood collection, analysed via ELISA.
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Brain volumes
Time Frame: Baseline and 12 months after surgery.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow-mediated dilatation (FMD; %)
Time Frame: Baseline, 4.5, 6, and 12 months after surgery.
Assessed via high-resolution ultrasound and semi-automated edge detection software.
Baseline, 4.5, 6, and 12 months after surgery.
Carotid intima-media thickness (cIMT; mm)
Time Frame: Baseline and 12 months after surgery.
Assessed via high-resolution ultrasound and semi-automated edge detection software.
Baseline and 12 months after surgery.
Pulse wave velocity (PWV; m/s)
Time Frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Assessed via the SphygmoCor XCEL System.
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Augmentation Index (AI)
Time Frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Assessed via the SphygmoCor XCEL System.
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Peripheral and Central blood pressures (mmHg)
Time Frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Assessed via the SphygmoCor XCEL System.
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Heart rate variability (HRV; ms2)
Time Frame: Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
This will be assessed as a composite outcome. Assessed via the Human Non-Invasive Blood Pressure System.
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.
Bone mineral density (g/cm2) of the hip
Time Frame: Baseline and 12 months after surgery.
Assessed via the Hologic Discovery W Dual Energy X-Ray (DEXA) Absorptiometry Scanner.
Baseline and 12 months after surgery.
Whole body fat-free mass (%)
Time Frame: Baseline and 12 months after surgery.
Assessed via the Hologic Discovery W Dual Energy X-Ray (DEXA) Absorptiometry Scanner.
Baseline and 12 months after surgery.
Total sleep time (mins)
Time Frame: Baseline and 12 months after surgery.
Assessed via the Nox-T3+ Device.
Baseline and 12 months after surgery.
Sleep efficiency (%)
Time Frame: Baseline and 12 months after surgery.
Assessed via the Nox-T3+ Device.
Baseline and 12 months after surgery.
Sleep-behaviours
Time Frame: Baseline and 12 months after surgery.
Assessed via validated questionnaires (STOP BANG, SAGIC, and Epworth Sleepiness Scale).
Baseline and 12 months after surgery.
Composite metabolic control
Time Frame: Baseline.
Glucose and insulin response to oral glucose tolerance test (75g) at 0, 30, 60, 120 minutes.
Baseline.
Diet quantity and quality
Time Frame: Baseline, 6 and12 months after surgery.
This will be assessed as a composite outcome. This will be assessed via a 3-day Food Diary, analysed with FoodWorks.
Baseline, 6 and12 months after surgery.
Changes in health-related quality of life
Time Frame: Baseline and 12 months after surgery.
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.
Baseline and 12 months after surgery.
Changes in social-related quality of life
Time Frame: Baseline and 12 months after surgery.
The Australian version of the Assessment of Quality of Life (AQoL).
Baseline and 12 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Collaborators

Washington University School of Medicine
Sydney Local Health District
Northern Sydney Local Health District

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X24-0053
  • ACTRN12624001065583 (Registry Identifier: Australian New Zealand Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

All IPD data arising from the trial will be shared two years after publication of the main results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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