Neurological Impact of Weight Reduction and Fitness Interventions
ConditionObesity and Overweight
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Sydney
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-80 years of age.
Eligible for bariatric surgery.
Willingness to provide informed consent and willingness to participate and comply with the study requirements
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralExercise.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: ExcerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Markers of neuroinflammation
Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI.
Time frame
Baseline and 12 months after surgery.Secondary outcomes
1
Cognitive function
This will be a composite outcome. Validated questionnaires such as Stroop Test.
Time frame
Baseline, 6 and 12 months after surgery.2
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.
Time frame
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.3
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.
Time frame
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.4
Brain volumes
Between groups and within groups at 12 months after randomisation with respect to baseline. Assessed via T1 and T2 MRI.
Time frame
Baseline and 12 months after surgery.Other outcomes
1
Flow-mediated dilatation (FMD; %)
Assessed via high-resolution ultrasound and semi-automated edge detection software.
Time frame
Baseline, 4.5, 6, and 12 months after surgery.2
Carotid intima-media thickness (cIMT; mm)
Assessed via high-resolution ultrasound and semi-automated edge detection software.
Time frame
Baseline and 12 months after surgery.3
Pulse wave velocity (PWV; m/s)
Assessed via the SphygmoCor XCEL System.
Time frame
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.4
Augmentation Index (AI)
Assessed via the SphygmoCor XCEL System.
Time frame
Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Charles Perkins Centre Clinic Status unavailable 2050, Royal Prince Alfred Hospital, New South Wales
Australia
AustraliaSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sydney
Lead sponsor
Washington University School of Medicine
Collaborator
Sydney Local Health District
Collaborator
Northern Sydney Local Health District
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: