Bariatric Surgery for Bariatric Surgery

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hamilton Health Sciences, Hamilton, Canada
Bariatric Surgery+1 More
Bariatric Surgery - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥35 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, cardiac structure and function, genomics, proteomics and metabolomics.

Eligible Conditions

  • Bariatric Surgery
  • Cardiovascular Complications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Through study completion, expected average of 6 years

Year 6
All-cause mortality
Cardiovascular Outcomes
Cardiovascular mortality
Change in quality of life assessed by EQ5D questionnaire
Change in quality of life assessed by Laval questionnaire
Change in weight
Cost effectiveness analysis, measured in quality adjusted life years
Hospitalization for heart failure
Myocardial infarction
New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring
New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines
Number of hospital admissions irrespective of cause
Number of participants with a new cancer diagnosis
Stroke

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Medical Weight Management
1 of 2
Bariatric Surgery
1 of 2
Active Control
Experimental Treatment

2000 Total Participants · 2 Treatment Groups

Primary Treatment: Bariatric Surgery · No Placebo Group · N/A

Bariatric Surgery
Procedure
Experimental Group · 1 Intervention: Bariatric Surgery · Intervention Types: Procedure
Medical Weight Management
Behavioral
ActiveComparator Group · 1 Intervention: Medical Weight Management · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bariatric Surgery
2016
Completed Phase 3
~14080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, expected average of 6 years
Closest Location: Hamilton Health Sciences · Hamilton, Canada
Photo of ontario 1Photo of ontario 2Photo of ontario 3
2009First Recorded Clinical Trial
0 TrialsResearching Bariatric Surgery
93 CompletedClinical Trials

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
140 Previous Clinical Trials
651,384 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a left ventricular ejection fraction (LVEF) of less than 40%.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.