New findings from a three-year observational extension of the landmark Diabetes Remission Clinical Trial DiRECT reveal that, for those in remission from type 2 diabetes at the end of year two of the original study, 26% still remained in remission at year five. The overall remission rate was 13% of those with data at 5 years.
The 5-year results break new ground, showing a halving of the number of serious medical events needing hospitalisation in those who received the diet intervention. Furthermore, the longer participants were able to maintain lower weight and remission of their type 2 diabetes, the less likely they were to suffer from some diabetes-related medical complications.
The important new findings, which are published in The Lancet Diabetes & Endocrinology, demonstrate how effective a weight management and diet programme can be for the control and remission of type 2 diabetes, highlighting the critical need for more clinical investment in diet-based therapies for the disease. Research is particularly needed to help people maintain the long-term weight losses required to achieve remission and other health benefits.
Designed and managed by researchers at the Universities of Glasgow and Newcastle and funded by Diabetes UK, the DiRECT trial proved highly effective at lowering blood pressure and reducing the need for anti-hypertensive medications, as well as bringing remissions of type 2 diabetes. DiRECT involved a 12-week 830-calorie formula diet to induce weight loss, followed by support to gradually reintroduce healthy meals from ordinary foods and maintain weight loss. The landmark trial was the first to show that remission from type 2 diabetes is possible through a dietary intervention programme in primary care, with almost half (46%) of people in remission at one year, and 36% at two years. With a weight loss of over 10 kg, 75% (three-quarters) of intervention group participants were in remission at both 1 and 2 years.
To investigate how much of the weight losses and remissions in the original two-year trial could be sustained – and whether there might be wider health benefits – the DiRECT-Extension study delivered a low-intensity weight-loss maintenance support programme to 95 participants who remained from the original DiRECT trial. Over the course of three years, participants received appointments at their GP surgery, or remotely during COVID-19 lockdowns, every three months to review their weight, blood sugar levels and blood pressure, and were offered advice and support to maintain their weight loss.
The DiRECT-Extension results demonstrated the continued effectiveness of prolonged weight management for the control and remission of type 2 diabetes. However, there was notable weight regain in some participants, especially up to year 3, underscoring the difficulty that maintaining weight loss poses – and also the need to find new ways to deliver this kind of support to patients. Importantly, however, those who maintained remission achieved an average weight loss of 8.9kg at five years.
Overall, at 5 years, those in the DiRECT-Extension group lost an average of 6.1kg. People in the original DiRECT control group who were receiving routine diabetes care, but with clear advice to lose weight, lost an average of 4.6kg. The original intervention group spent more of the 5 years than the original control group with weight over 5% below baseline (61% vs 29%), with HbA1c below the diabetes threshold of 48 mmol/mol (29% vs 15%), without needing anti-diabetes medication (51% vs 16%), and in remission (27% vs 4%). Of those in remission at year-2, over a quarter (26%) remained in remission at 5 years.
In keeping with results from other studies, the 5-year results also suggested wider health benefits from the diet intervention. Those in the original DiRECT intervention group had under half the number of illnesses needing hospital admission (4.8 events per 100 patient-years) than the original DiRECT control group (10.2 events per 100 patient-years), and participants had fewer diabetes-related clinical events if they maintained weight losses, lower HbA1c and remissions.
Professor Mike Lean, who co-designed the original DiRECT trial, and is the senior author of the latest DiRECT-Extension study, said: “Previously considered permanent, requiring life-long drug treatment, type 2 diabetes is now recognised to be a potentially reversible consequence of excessive or abnormal accumulation of body fat. When fat accumulates in vital organs, like liver, pancreas or heart, these organs stop functioning normally. Weight loss of 10-15kg (about 2 stones) is enough to remove that abnormal fat from vital organs, and the key to any type 2 remission.
“DiRECT has made a world-wide paradigm-shift in understanding and treating type 2 diabetes. The disease is not necessarily permanent, and the 5-year results now suggest that diet treatment for weight loss to achieve a period of remission is likely to be accompanied by greater freedom from some diabetes complications and fewer people being admitted to hospital with medical problems.
“We must now call for much more effective, long-term funding for research to improve on these results – especially to prevent weight regain. However the evidence means that we should no longer merely reduce high blood sugar with medication, but to try to check the underlying disease-process with effective weight management as a priority when type 2 diabetes is diagnosed. Previous research has shown that people who have type 2 diabetes but who are not overweight have excess or anormal body fat, and may be able to achieve remission with quite modest weight loss. New drugs being developed for type 2 diabetes and obesity are exciting, but they should not be prescribed without sound dietary weight-management.”
Professor Roy Taylor, from Newcastle University, who co-designed the original DiRECT trial, and is a senior author of the latest DiRECT-Extension study, said: “This five-year study demonstrates that long-term remission from type 2 diabetes is possible if sufficient weight loss is achieved and maintained.
“Whether or not remission of diabetes was achieved, those people who were assigned to the weight loss group had less than half of the serious health issues experienced by the conventionally treated group. These are encouraging outcomes which should help change how this serious condition is managed.”
Dr Elizabeth Robertson, Director of Research at Diabetes UK, said: “Diabetes UK is proud to have funded over a decade of research that has forged new frontiers for people with type 2 diabetes and put remission on the map. Remission from type 2 diabetes lifts the burden of 24/7 diabetes-management and can transform health and wellbeing. But we know that going into remission can be challenging and staying there even more so. That’s why we’ve just launched our new remission information and support hub and are continuing to fund research to understand how to help more people go into remission and stay there for longer.”
The study, ‘Five-year follow-up of the randomised Diabetes Remission Clinical Trial (DiRECT): Extension study of continued support for weight loss maintenance’ is published in The Lancet Diabetes & Endocrinology. The work was funded by Diabetes UK.
Further information about DiRECT and resources for remission can be found on
https://www.directclinicaltrial.org.uk/
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