Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial

John Wentworth, Julie Marie Playfair, Cheryl Laurie, Matthew E Ritchie, Wendy Ann Brown, Paul Robert Burton, Jonathan Edward Shaw, Paul Edmond O'Brien

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116 Citations (Scopus)

Abstract

Background: Bariatric surgery improves glycaemia in obese people with type 2 diabetes, but its effects are uncertain in overweight people with this disease. We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese. Methods: We did an open-label, parallel-group, randomised controlled trial between Nov 1, 2009, and June 30, 2013, at one centre in Melbourne, Australia. Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned (1:1), by computer-generated random sequence, to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone. The primary outcome was diabetes remission 2 years after randomisation, defined as glucose concentrations of less than 7?0 mmol/L when fasting and less than 11?1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000286246. Findings: 51 patients were randomised to the multidisciplinary care plus gastric band group (n=25) or the multidisciplinary care only group (n=26), of whom 23 participants and 25 participants, respectively, completed follow-up to 2 years. 12 (52 ) participants in the multidisciplinary care plus gastric band group and two (8 ) participants in the multidisciplinary care only group achieved diabetes remission (difference in proportions 0?44, 95 CI 0?17-0?71; p=0?0012). One (4 ) participant in the gastric band group needed revisional surgery and four others (17 ) had a total of five episodes of food intolerance due to excessive adjustment of the band. Interpretation: When added to multidisciplinary care, laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile. Laparoscopic adjustable gastric band surgery is a reasonable treatment option for this population. Funding: Monash University Centre for Obesity Research and Education and Allergan.
Original languageEnglish
Pages (from-to)545 - 552
Number of pages8
JournalThe Lancet Diabetes and Endocrinology
Volume2
Issue number7
DOIs
Publication statusPublished - 2014

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