The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
Bariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards.
The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care
Hamilton Health Sciences
Hamilton, Ontario, Canada
RECRUITINGCardiovascular Outcomes
Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF).
Time frame: Through study completion, expected average of 6 years
BRAVE-Mind Sub-study Measures
1. Depressive symptoms asessed with the Patient Health Questionnaire-8 (PHQ-8) 2. Global cognitive function assessed with the Montreal Cognitive Assessment (MoCA) Secondary Outcome Measures: 3. Executive function and processing speed assessed with the Number Symbol Coding Task (NSCT) 4. Functional capacity assessed with the Standardized Assessment of Global Activities in the Elderly (SAGE) 5. Anxiety symptoms assessed with the Generalized Anxiety Disorder-7 (GAD-7) 6. Nonnormative eating symptoms assessed with the Loss of Control Over Eating-Brief (LOCES-B)
Time frame: 3 years
All-cause mortality
Time frame: Through study completion, expected average of 6 years
Cardiovascular mortality
Time frame: Through study completion, expected average of 6 years
Myocardial infarction
Time frame: Through study completion, expected average of 6 years
Stroke
Time frame: Through study completion, expected average of 6 years
Hospitalization for heart failure
Time frame: Through study completion, expected average of 6 years
New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines
Time frame: Through study completion, expected average of 6 years
New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring
Time frame: Through study completion, expected average of 6 years
Cost effectiveness analysis, measured in quality adjusted life years
Economic evaluation to compare the costs and health outcomes associated with bariatric surgery and medical weight management
Time frame: Through study completion, expected average of 6 years
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