title: Effects of gastric bypass surgery in patients with hypertension: rationale and design for a randomised controlled trial (GATEWAY study).
abstract: BACKGROUND
  Obesity and overweight are becoming progressively more prevalent worldwide and are independently associated with a significant increase in the risk of cardiovascular diseases. Systemic arterial hypertension is frequently found in association with obesity and contributes significantly to increased cardiovascular risk. We hypothesise that Roux-en-Y gastric bypass (RYGB) surgery, a procedure that effectively reduces body weight, can also positively impact blood pressure control in obese and hypertensive individuals.
  
  
  METHODS
  A unicentric, randomised, controlled, unblinded clinical trial. Sixty obese (body mass index between 30 and 39.9) and moderately well controlled hypertensive patients, in use of at least two antihypertensive medications at maximum doses or more than two in moderate doses, will be randomly allocated, using an online, electronic and concealed method, to receive either RYGB plus optimised clinical treatment (OCT) or OCT alone. The primary end point is the reduction of antihypertensive medication at 1 and 2 years of follow-up. Data analysis will primarily be conducted on an intention-to-treat basis.
  
  
  BACKGROUND
  The study was approved by the local institutional review board that works in total compliance with the latest version of the Helsinki Declaration, 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 signed informed consent.
  
  
  BACKGROUND
  NCT01784848.
authors.affiliation: Research Institute HCor (Hospital do Coração, Heart Hospital) São Paulo, São Paulo, Brazil.
authors.forename: Carlos Aurélio
authors.initials: CA
authors.lastname: Schiavon
authors.affiliation: Research Institute HCor (Hospital do Coração, Heart Hospital) São Paulo, São Paulo, Brazil.
authors.forename: Dimas Tadahiro
authors.initials: DT
authors.lastname: Ikeoka
authors.affiliation: Department of Hypertension, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Marcio Gonçalves
authors.initials: MG
authors.lastname: de Sousa
authors.affiliation: Research Institute HCor (Hospital do Coração, Heart Hospital) São Paulo, São Paulo, Brazil.
authors.forename: Cellys Roberta Ananias
authors.initials: CR
authors.lastname: Silva
authors.affiliation: Research Institute HCor (Hospital do Coração, Heart Hospital) São Paulo, São Paulo, Brazil.
authors.forename: Angela Cristine
authors.initials: AC
authors.lastname: Bersch-Ferreira
authors.affiliation: Hospital do Coração, Hcor, São Paulo, Brazil.
authors.forename: Juliana Dantas
authors.initials: JD
authors.lastname: de Oliveira
authors.affiliation: Hospital do Coração, Hcor, São Paulo, Brazil.
authors.forename: Patrícia Malvina
authors.initials: PM
authors.lastname: Noujaim
authors.affiliation: BAROS-Instituto de Cirurgia Avançada, São Paulo, Brazil.
authors.forename: Ricardo Vitor
authors.initials: RV
authors.lastname: Cohen
authors.affiliation: Department of Hypertension, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil Hospital do Coração, Hcor, São Paulo, Brazil.
authors.forename: Celso
authors.initials: C
authors.lastname: Amodeo
authors.affiliation: Research Institute HCor (Hospital do Coração, Heart Hospital) São Paulo, São Paulo, Brazil.
authors.forename: Otávio
authors.initials: O
authors.lastname: Berwanger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D015390:Gastric Bypass; D006801:Humans; D006973:Hypertension / Q000209:etiology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000601:surgery*; D055815:Young Adult
keywords: NUTRITION & DIETETICS