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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sydney

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Obesity and Overweight

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings