The DIRECT (DIabetes REmission Clinical Trial) study: Remission of Type 2 diabetes using non-surgical weight management with low energy liquid diet and long-term maintenance within routine NHS care
In 2011, researchers funded by Diabetes UK used a low-calorie diet to investigate the mechanisms by which Type 2 diabetes can be put into remission. Now, with support from our single largest grant ever, Professor Mike Lean and Professor Roy Taylor will investigate the long-term outcomes of this approach as part of routine GP care. Their vital work will find out if a low-calorie diet can help to stem the rising tide of Type 2 diabetes.
Background to research
Not everyone with Type 2 diabetes is overweight, but obesity and adult weight gain in particular are the most important risk factors for this condition – and can be modified relatively easily. Studies have shown that surgical operations, such as gastric banding and gastric bypass, are potential solutions to Type 2 diabetes, because they lead to dramatic weight loss that can put Type 2 into remission for up to 80% of patients. However, surgery is expensive, invasive and carries a risk of surgical complications, all of which mean that it can only be offered as a last resort to people who are dangerously obese and not to everyone whose diabetes might benefit from significant weight loss.In 2011, Diabetes UK funded a groundbreaking research trial at Newcastle University that aimed to mimic the effects of weight loss surgery using a less invasive approach and to clarify the mechanisms behind Type 2 remission. Under close supervision from a medical team, participants in this initial study were put on a strict diet of around 800 calories a day, which consisted of liquid diet drinks and non-starchy vegetables. Within seven days, levels of fat in their livers had decreased sharply. By the end of the study, levels of fat in the pancreas had also decreased and production of insulin at mealtimes had returned to normal. Some of the participants later regained weight but, after two months, everyone who took part in the study was in remission from Type 2 diabetes and, three months later, most still had normal blood glucose control. To build on the success of this trial, Diabetes UK called for new research ideas to find out if this approach can be used safely as part of long-term weight management within routine GP care and to help put Type 2 diabetes into remission and keep it there.
With the largest single grant in Diabetes UK history, researchers led by Professor Mike Lean at the University of Glasgow and Professor Roy Taylor at Newcastle University will compare the long-term health effects of weight management (using a low-calorie diet followed by long-term weight control) with the best Type 2 diabetes care that is currently available. People aged 20-65 who have been diagnosed with Type 2 diabetes in the last six years will be recruited from their GP practices across Scotland and Tyneside and will receive either the current best-available care or a low-calorie liquid diet. The diet will last for between 8 and 20 weeks and provide approximately 800 calories a day. It will consist of four diet soups or shakes per day providing all essential vitamins and minerals, plus ample fluids.Those who complete the diet will be gradually re-introduced to normal food over a period of two to eight weeks and will then receive expert support to help them maintain their weight loss in the longer-term. Some of the participants from Tyneside will also undergo MRI scans at Newcastle University to help the researchers understand in precise detail how significant weight loss can lead to Type 2 diabetes remission. In addition, the researchers will survey the opinions of people with Type 2 diabetes and healthcare professionals who take part in the study, to help them identify challenges and work out how a low-calorie diet might be used most effectively in routine GP care.
Potential benefit to people with diabetes
Type 2 diabetes is currently seen as a condition that worsens inevitably over time, until it must be managed using insulin injections. If this study shows that a low-calorie diet can be used safely and effectively to support weight management and bring about Type 2 diabetes remission for two years or more, it will inform and optimise future research and practice and could completely change the way that this condition is viewed.Specifically, a practical and effective approach that uses weight control to bring about and maintain Type 2 diabetes remission could lead to significant changes in the way that Type 2 diabetes is managed by the NHS. It could also provide an accessible way to help people with this condition live for longer with an improved quality of life and a reduced risk of serious health complications, without the need for invasive weight loss surgery. Ultimately, if weight management within routine GP care can be used to bring about and maintain long-term Type 2 diabetes remission, it could be of enormous benefit to millions of people living with Type 2 diabetes in the UK.