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. Issue 6 (19th November 2012)

• Record Type: Journal Article
• Authors: Mingrone, Geltrude; Panunzi, Simona; De Gaetano, Andrea; Guidone, Caterina; Raffaelli, Marco; Callari, Cosimo; Lombardi, Pio Celestino; Bellantone, Rocco
• Is Part Of: BMJ open. Volume 2:Issue 6(2012)
• Publication Date: 2012-11-19
• Subjects: Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2012-002184
• Languages: English
• ISSNs: 2044-6055

Abstract

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 .