Recruiting

Bariatric Surgery

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT04226664

Conditions

Obesity, Morbid

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bariatric surgery

Study Details

Brief summary:

Pilot multicentre, open-label, parallel-arm randomized controlled trial (RCT) of 60 patients to demonstrate the feasibility of enrolling patients with high-risk cardiovascular disease (CVD) into an RCT of bariatric surgery versus medical weight management (MWM).

Conditions

Obesity, Morbid

Cardiovascular Diseases

Study ID

NCT04226664

Start date

Oct 30, 2020

Status verified date

Mar, 2022

Completion date

May, 2023

Anticipated

Primary completion date

Feb, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Body mass index >35 kg/m2
2. Age ≥18 years
3. High-risk CVD, defined as the presence of any one of the following:

1. History of MI, multi-vessel percutaneous coronary intervention or multi-vessel coronary artery bypass grafting; OR
2. Coronary artery disease (CAD) with documented stenoses ≥50% in 2 or more major coronary arteries; OR
3. Symptomatic HF (New York Heart Association class ≥2) on optimal HF therapy for ≥3 months, AND documented HF hospitalization within the last 12 months, OR baseline N-terminal pro B-type natriuretic peptide (NT-pro BNP) >400 pg/ml;44, 45 OR
4. Documented AF with CHA2DS2-VASc stroke risk score (congestive heart failure/ left ventricular dysfunction, hypertension, age ≥ 75 years \[2 points\], diabetes, history of stroke/ transient ischemic attack \[2 points\], vascular disease, age 65-74 years and female sex) of ≥2; OR
5. History of ischemic stroke; OR
6. Peripheral artery disease, defined as prior aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, infra-inguinal arteries or carotids; or limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis
4. Patient is deemed eligible to undergo bariatric surgery according to local practice guidelines

Exclusion Criteria:

1. Hospital admission for HF within 30 days of enrolment
2. Myocardial infarction, stroke or coronary revascularization in prior 30 days.
3. Percutaneous coronary intervention with a drug eluting stent in prior 90 days.
4. Pregnancy
5. Contraindication to bariatric surgery (atrophic gastritis, diabetes mellitus type 1, prior laparotomy, liver cirrhosis with portal hypertension, uncontrolled drug or alcohol dependence, prior bariatric surgery, massive ventral hernia, severe chronic obstructive pulmonary disease)
6. Life expectancy <2 years from non-cardiovascular causes.
7. Risk of general anesthesia deemed too excessive
8. Current drug or alcohol dependency (within 6 months of referral)
9. Recent major cancer (life threatening, within last 2 years)
10. Untreated or inadequately treated psychiatric illness
11. Inability to provide informed consent

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention

Bariatric surgery will consist of laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy performed at the discretion of the surgeon and according to local standards.

no intervention: Control

Medical Weight Management (MWM) corresponds to the standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care.

Interventions

Bariatric surgery

Although there may be slight variation by centre, Gastric Bypass generally involves creation of a 30-50 cc stomach pouch, which is anastamosed with a Roux limb of jejunum 75-100 cm in length and a biliary limb of 20-30 cm in length. The operation creates a small gastric pouch, with nutrients bypassing the duodenum and proximal jejunum. Sleeve Gastrectomy involves decreasing the size of the stomach to approximately 15% of its original size by resecting a large portion of the stomach along the greater curvature.

Primary outcome measure

  • Recruitment rate [ Time Frame: 24 months (or when recruitment is complete) ]
  • Time to intervention administration [ Time Frame: 30 days ]
  • Crossover rate [ Time Frame: At study completion (an average of 1.5 years follow-up) ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Principal Investigator:

Aristithes Doumouras, MD MPH FRCSC

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Mar 15, 2022

Last verified

Mar, 2022

Keywords

  • Bariatric Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2022-03-15.