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

Abstract

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 20/12/2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12875-016-0406-2) contains supplementary material, which is available to authorized users.

Exploring the provision of diabetes nutrition education by practice nurses in primary care settings

“…Nurses’ strong beliefs in the benefits of NE on health outcomes were evident in the present study. Subsequent dissemination of the DiRECT study findings, which demonstrates that diabetes remission is attainable through weight loss, should strengthen this further . As a result of DiRECT, services are re‐designing diabetes care to introduce a local remission service.…”

Very low‐energy and low‐energy formula diets: Effects on weight loss, obesity co‐morbidities and type 2 diabetes remission – an update on the evidence for their use in clinical practice

“…Protocols for managing T2D and blood pressure medications when using a formula diet are published in the DiRECT study protocol and the Doctor Referral of Overweight People to Low‐Energy total diet replacement Treatment ( DROPLET) study paper (Leslie et al . ; Astbury et al . ).…”

“…Anti-hypertensive medication should also be reviewed to avoid low blood pressure, which is a common side effect in those using formula VLEDs or LEDs. Protocols for managing T2D and blood pressure medications when using a formula diet are published in the DiRECT study protocol and the Doctor Referral of Overweight People to Low-Energy total diet replacement Treatment (DROPLET) study paper (Leslie et al 2016;Astbury et al 2018). Furthermore, it is essential that patients that do achieve T2D remission should continue to be monitored for T2D-related complications and also deterioration of glycaemic control at least annually (Diabetes UK 2018).…”

Very Low-Calorie Diets in Type 2 Diabetes Mellitus: Effects on Inflammation, Clinical and Metabolic Parameters

“…A rapid decrease in liver and pancreas fat content derived from weight loss was linked to the glucoselowering effects elicited by VLCD [18]. Later on, the same group of researchers showed that a higher baseline plasma insulin levels, preserved β-cell function and lower duration of diabetes were linked to diabetes remission following a VLCD regimen (624-700 kcal/day) for at least be investigated and ongoing clinical trials are in the run [30] to provide more solid and clear evidence, as to if diabetes remission is possible by considerably changing the way people eat, without the necessity of invasive procedures (i.e., bariatric surgery).…”