The Standard reports that the UK's National Health Service (NHS) Diabetes Prevention Programme (NHS DPP) will see up to 5,000 patients prescribed a liquid diet of just over 800 calories a day for three months, following the first-year results of the Diabetes UK DiRECT study.
The regime put patients recently diagnosed with type 2 diabetes in remission, while a quarter of participants lost more than 15kg.
Overall, the DPP – a nine-month lifestyle programme for people who are at risk of type 2 – will double in size to treat around 200,000 people a year. It helps patients achieve a healthy weight, improve their overall nutrition and increase levels of physical activity.
The report says the NHS spends around 10% of its budget on treating diabetes, and it is hoped the move will save money that can be reinvested in front-line care. The approach follows the Diabetes UK-funded DiRECT trial, where almost half of those who went on a very low-calorie diet achieved remission of their type 2 diabetes after a year. A quarter of participants achieved 15kg or more weight loss, and 86% of these put their type 2 diabetes into remission.
NHS England CEO Simon Stevens is quoted in the report as saying: “The NHS is now going to be ramping up practical action to support hundreds of thousands people avoid obesity-induced heart attacks, strokes, cancers and type 2 diabetes. “The NHS long-term plan is going to give people the power and the support to take control of their own lifestyles, so that they can help themselves while also helping the NHS.”
Chris Askew, CEO of Diabetes UK, added: “The first-year results of Diabetes UK DiRECT study showed that – for some people with type 2 diabetes – an intensive, low-calorie weight loss programme delivered with ongoing support through primary care could put their condition into remission.”
Background: The DiRECT trial assessed remission of type 2 diabetes during a primary care-led weight-management programme. At 1 year, 68 (46%) of 149 intervention participants were in remission and 36 (24%) had achieved at least 15 kg weight loss. The aim of this 2-year analysis is to assess the durability of the intervention effect.
Methods: DiRECT is an open-label, cluster-randomised, controlled trial done at primary care practices in the UK. Practices were randomly assigned (1:1) via a computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700 people). Allocation was concealed from the study statisticians; participants, carers, and study research assistants were aware of allocation. We recruited individuals aged 20–65 years, with less than 6 years' duration of type 2 diabetes, BMI 27–45 kg/m 2, and not receiving insulin between July 25, 2014, and Aug 5, 2016. The intervention consisted of withdrawal of antidiabetes and antihypertensive drugs, total diet replacement (825–853 kcal per day formula diet for 12–20 weeks), stepped food reintroduction (2–8 weeks), and then structured support for weight-loss maintenance. The coprimary outcomes, analysed hierarchically in the intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes, defined as HbA 1c less than 6·5% (48 mmol/mol) after withdrawal of antidiabetes drugs at baseline (remission was determined independently at 12 and 24 months). The trial is registered with the ISRCTN registry, number 03267836, and follow-up is ongoing.
Findings: The intention-to-treat population consisted of 149 participants per group. At 24 months, 17 (11%) intervention participants and three (2%) control participants had weight loss of at least 15 kg (adjusted odds ratio [aOR] 7·49, 95% CI 2·05 to 27·32; p=0·0023) and 53 (36%) intervention participants and five (3%) control participants had remission of diabetes (aOR 25·82, 8·25 to 80·84; p<0·0001). The adjusted mean difference between the control and intervention groups in change in bodyweight was −5·4 kg (95% CI −6·9 to −4·0; p<0·0001) and in HbA 1c was −4·8 mmol/mol (–8·3 to −1·4 [–0·44% (–0·76 to −0·13)]; p=0·0063), despite only 51 (40%) of 129 patients in the intervention group using anti-diabetes medication compared with 120 (84%) of 143 in the control group. In a post-hoc analysis of the whole study population, of those participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss. Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22).
Interpretation: The DiRECT programme sustained remissions at 24 months for more than a third of people with type 2 diabetes. Sustained remission was linked to the extent of sustained weight loss.
Funding: Diabetes UK.
Michael EJ Lean, Wilma S Leslie, Alison C Barnes, Naomi Brosnahan, George Thom, Louise McCombie, Carl Peters, Sviatlana Zhyzhneuskaya, Ahmad Al-Mrabeh, Kieren G Hollingsworth, Angela M Rodrigues, Lucia Rehackova, Ashley J Adamson, Falko F Sniehotta, John C Mathers, Hazel M Ross, Yvonne McIlvenna, Paul Welsh, Sharon Kean, Ian Ford, Alex McConnachie, Claudia-Martina Messow, Naveed Sattar, Roy Taylor