title: Protocol for a randomised clinical study comparing the effect of Roux-en-Y gastric bypass and sleeve gastrectomy on reactive hypoglycaemia in morbidly obese subjects.
abstract: BACKGROUND
  Roux-en-Y gastric bypass (RYGB) is the most performed bariatric operation. Reactive hypoglycaemia is a frequent late complication occurring in about 72% of RYGB patients, which can present with various intensities up to the serious form of neuroglycopaenia. However, it seems to occur also after sleeve gastrectomy (SG) although much more rarely.
  
  
  METHODS
  A single centre, open, 1-year randomised trial to compare the incidence of hypoglycaemia after RYGB or SG. A secondary objective is the assessment of the comparative ability of the two surgical procedures in determining the improvement or normalisation of insulin sensitivity, given the established relevance of insulin resistance in the cardiometabolic syndrome of obesity.
  
  
  BACKGROUND
  The study will be published and presented to international meetings and, due to the safety issue, it will represent a relevant information for national healthcare systems. The protocol was approved by the Catholic University Ethical Committee (A1534/CE/2012). Clinicaltrials.gov Registration n. NCT01581801.
authors.affiliation: Department of Internal Medicine,  Catholic University, Rome,  Italy.
authors.forename: Geltrude
authors.initials: G
authors.lastname: Mingrone
authors.forename: Simona
authors.initials: S
authors.lastname: Panunzi
authors.forename: Andrea
authors.initials: A
authors.lastname: De Gaetano
authors.forename: Caterina
authors.initials: C
authors.lastname: Guidone
authors.forename: Marco
authors.initials: M
authors.lastname: Raffaelli
authors.forename: Cosimo
authors.initials: C
authors.lastname: Callari
authors.forename: Pio Celestino
authors.initials: PC
authors.lastname: Lombardi
authors.forename: Rocco
authors.initials: R
authors.lastname: Bellantone