NCT06830252Not yet recruiting
Neurological Impact of Weight Reduction and Fitness Interventions
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
Source: ClinicalTrials.gov · Last updated 17 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Sydney
- Diseases
- Obesity
- NCT number
- NCT06830252
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Feb 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-MRI-compatible implanted devices or implants.
- Concurrent participation in any other interventional study.
Other illness
- 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.
- Psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder).
Other
- Unable to undertake MRI due to size restrictions i.e., shoulder width more than 70 cm.
- Inability to exercise via supine ergometer.
- Claustrophobia.
- 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.
Who the study is looking for
- 18-80 years of age.
- Eligible for bariatric surgery.
- Willingness to provide informed consent and willingness to participate and comply with the study requirements
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charles Perkins Centre Clinic Coordinator of this site? Confirm its status | Royal Prince Alfred Hospital | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.