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

Leslie, W. S. et al. (2016) The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial. BMC Family Practice, 17(1), (doi: 10.1186/s12875-016-0406-2) (PMID:26879684) (PMCID:PMC4754868)

Abstract

Background: Despite 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/Design: Cluster-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. Discussion: This 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.

• Item Type: Articles
• Additional Information: The DiRECT study is funded as a Strategic Research Initiative by Diabetes UK.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Brosnahan, Dr Naomi and Lean, Professor Michael and Kean, Ms Sharon and McIlvenna, Ms Yvonne and Thom, Dr George and Sattar, Professor Naveed and Ford, Professor Ian and Leslie, Dr Wilma
• Authors: Leslie, W. S., Ford, I., Sattar, N., Hollingsworth, K. G., Adamson, A., Sniehotta, F. F., McCombie, L., Brosnahan, N., Ross, H., Mathers, J. C., Peters, C., Thom, G., Barnes, A., Kean, S., McIlvenna, Y., Rodrigues, A., Rehackova, L., Zhyzhneuskaya, S., Taylor, R., and Lean, M. E.J.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: BMC Family Practice
• Publisher: BioMed Central
• ISSN: 1471-2296
• ISSN (Online): 1471-2296
• Published Online: 16 February 2016
• Copyright Holders: Copyright © 2016 Leslie et al.
• First Published: First published in BMC Family Practice 17:20
• Publisher Policy: Reproduced under a creative commons license