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.

Geltrude Mingrone, Marco Raffaelli, Celestino Pio Lombardi, Rocco Domenico Alfonso Bellantone, Simona Panunzi, Andrea De Gaetano, Caterina Guidone, Cosimo Callari

Research output: Contribution to journalArticle

Abstract

INTRODUCTION: 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 AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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.
Original languageEnglish
Pages (from-to)1-2
Number of pages2
JournalBMJ. BRITISH MEDICAL JOURNAL
Publication statusPublished - 2012

Keywords

  • Roux-en-Y gastric bypass
  • morbidly obese subjects
  • sleeve gastrectomy

Fingerprint

Dive into the research topics of '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.'. Together they form a unique fingerprint.

Cite this