The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial

BMC Family Practice

Study Protocol

Louise McCombie¹  Hazel Ross¹  Alison Barnes²  Lucia Rehackova²  Carl Peters²  Falko F. Sniehotta²  John C. Mathers²  Kieren G. Hollingsworth²  Ashley Adamson²  Angela Rodrigues²  Roy Taylor²  Sviatlana Zhyzhneuskaya²  Wilma S. Leslie³  Naveed Sattar³  George Thom³  Sharon Kean³  Yvonne McIlvenna³  Ian Ford³  Naomi Brosnahan³  Mike E. J. Lean³ 

[1] Counterweight Ltd, Edinburgh, UK;Newcastle University, NE1 7RU, Newcastle upon Tyne, Tyne and Wear, UK;University of Glasgow, University Avenue, G12 8QQ, Glasgow, UK;

关键词: Type 2 diabetes;    Weight management;    Total diet replacement;    Primary care;   

DOI  :  10.1186/s12875-016-0406-2

 received in 2015-12-27, accepted in 2016-01-21,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundDespite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33 % of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion.The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response.Methods/DesignCluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m2. Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years.DiscussionThis study will establish whether a structured weight management programme, delivered in Primary Care by practice nurses or dietitians, is a viable treatment to achieve T2DM remission. Results, available from 2018 onwards, will inform future service strategy.Trial registrationCurrent Controlled Trials ISRCTN03267836. Date of Registration 20/12/2013

【 授权许可】

CC BY   
© Leslie et al. 2016