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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Weight Management | Active Comparator | MWM corresponds to standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care. MWM will typically consist of dietary, lifestyle and/or behavioral modification counseling, which may include nutritional counseling, safe weight management and/or making healthy lifestyle changes. MWM may also include the implementation of a low caloric diet, which may comprise the use of adjuvant meal replacements and/or anti-obesity mediations at the discretion of the treating physician and according to local practice guidelines. |
|
| Bariatric Surgery | Experimental | The bariatric surgery procedures performed in BRAVE include either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards. Sleeve gastrectomy will be performed as a stand-alone procedure, but may also be performed as part of a planned duodenal switch. Gastric banding is not permitted. Patients may receive a low fat, high protein meal replacement preceding surgery to reduce the size of the liver. Perioperative use of aspirin, thienopyridines (clopidogrel, ticagrelor or prasugrel), and anti-thrombotic therapy (compression stockings and subcutaneous heparin) should follow local guidelines and will be left at the discretion of the individual surgeons. . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric Surgery | Procedure | Bariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Outcomes | Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF). | Through study completion, expected average of 6 years |
| BRAVE-Mind Sub-study Measures |
| 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Through study completion, expected average of 6 years | |
| Cardiovascular mortality | Through study completion, expected average of 6 years | |
| Myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life assessed by EQ5D questionnaire | Through study completion, expected average of 6 years | |
| Change in quality of life assessed by Laval questionnaire | Through study completion, expected average of 6 years |
Inclusion Criteria:
Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are >55 years of age
Age ≥18 years
High-risk CVD, defined as the presence of any one of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge Wong, MD, MPH, FRCPC | Contact | 905-521-2100 | 40309 | jorge.wong@phri.ca |
| Sumathy Rangarajan, MSc | Contact | 905-296-5792 | sumathy.rangarajan@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Medical Weight Management | Behavioral | The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care |
|
| Through study completion, expected average of 6 years |
| Stroke | Through study completion, expected average of 6 years |
| Hospitalization for heart failure | Through study completion, expected average of 6 years |
| New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines | Through study completion, expected average of 6 years |
| New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring | 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 | Through study completion, expected average of 6 years |
| Change in weight | Through study completion, expected average of 6 years |
| Number of hospital admissions irrespective of cause | Through study completion, expected average of 6 years |
| Number of participants with a new cancer diagnosis | Through study completion, expected average of 6 years |