Effects of gastric bypass surgery inpatients with hypertension: rationaleand design for a randomised controlledtrial (GATEWAY study)

ABSTRACT

Obesity and overweight are becomingprogressively more prevalent worldwide and areindependently associated with a significant increase inthe risk of cardiovascular diseases. Systemic arterialhypertension is frequently found in association withobesity and contributes significantly to increasedcardiovascular risk. We hypothesise that Roux-en-Ygastric bypass (RYGB) surgery, a procedure thateffectively reduces body weight, can also positivelyimpact blood pressure control in obese andhypertensive individuals.Methods and analysis: A unicentric, randomised,controlled, unblinded clinical trial. Sixty obese (bodymass index between 30 and 39.9) and moderately wellcontrolled hypertensive patients, in use of at least twoantihypertensive medications at maximum doses ormore than two in moderate doses, will be randomlyallocated, using an online, electronic and concealedmethod, to receive either RYGB plus optimised clinicaltreatment (OCT) or OCT alone. The primary end pointis the reduction of antihypertensive medication at1 and 2 years of follow-up. Data analysis will primarilybe conducted on an intention-to-treat basis.Ethics and dissemination The study was approvedby the local institutional review board that works intotal compliance with the latest version of the HelsinkiDeclaration, the Good Clinical Practices (GCP), the‘America’s Document’ and the national regulatory laws.Before the beginning of any study-related activities,each study participant is asked to provide a signedinformed consent.