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.

Not Applicable

• Conditions: Obesity; Neuroinflammation; Diet and Nutrition - Obesity; Neurological - Other neurological disorders

• Registration Number: ACTRN12624001065583
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-03
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: Interventional
• Study Design: Not specified