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DiRECT trial

DiRECT trial: low calorie diet reverses type 2 diabetes

Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group ( p<0·0001)

Almost half of the patients with Type 2 diabetes supported by their GPs on a weight loss programme were able to reverse their diabetes in a year, according to the results of the DiRECT (Diabetes Remission Clinical Trial. The one-year results also revealed that almost nine out of 10 people (86%) who lost 15kg or more put their Type 2 diabetes into remission.

The study led by Professor Roy Taylor, from Newcastle University, and Professor Mike Lean from Glasgow University, found that 45.6% of those who were put on a low-calorie diet for three to five months and were able to stop their Type 2 diabetes medications. Importantly, long-term support by routine General Practice staff was given to help the participants maintain their weight loss. The findings were presented at the International Diabetes Federation Congress in Abu Dhabi by the lead researchers, Professors Taylor Lean.

Roy Taylor (Credit: Newcastle University)

"These findings are very exciting. They could revolutionise the way Type 2 diabetes is treated. The study builds on the work into the underlying cause of the condition, so that we can target management effectively,” said Taylor. "Substantial weight loss results in reduced fat inside the liver and pancreas, allowing these organs to return to normal function. What we're seeing from DiRECT is that losing weight isn't just linked to better management of Type 2 diabetes: significant weight loss could actually result in lasting remission."

The one-year outcomes were reported in the paper, ‘Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial’, published in The Lancet. DiRECT is a two-year trial, which aims to find an effective and accessible way to put Type 2 diabetes into remission for the long-term and whether intensive weight management within routine primary care would achieve remission of type 2 diabetes.

The open-label, cluster-randomised trial recruited 298 people at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician.

Patients recruited were aged 20–65 years who had been diagnosed with type 2 diabetes within the past six years, had a BMI27–4 and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825–853kcal/day formula diet for 3–5 months), stepped food reintroduction (2–8 weeks), and structured support for long-term weight loss maintenance.

Co-primary outcomes were weight loss of 15kg or more and remission of diabetes - defined as glycated haemoglobin (HbA1c) of less than 6·5% (<48mmol/mol) after at least 2 months off all antidiabetic medications from baseline to 12 months.

Outcomes

At 12 months, the investigators recorded weight loss of 15kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19.7, 95% CI 7.8–49.8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0–5kg weight loss, 19 (34%) of 56 participants with 5–10kg loss, 16 (57%) of 28 participants with 10–15kg loss, and 31 (86%) of 36 participants who lost 15kg or more.

"Putting Type 2 diabetes into remission as early as possible after diagnosis could have extraordinary benefits, both for the individual and the NHS."

They reported that mean bodyweight fell by 10.0kg (SD 8.0) in the intervention group and 1.0kg (3.7) in the control group (adjusted difference −8.8 kg, 95% CI −10.3 to −7.3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7.2 points (SD 21.3) in the intervention group, and decreased by 2.9 points (15.5) in the control group (adjusted difference 6.4 points, 95% CI 2.5–10.3; p=0·0012).

Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study.

"Putting Type 2 diabetes into remission as early as possible after diagnosis could have extraordinary benefits, both for the individual and the NHS. DiRECT is telling us it could be possible for as many as half of patients to achieve this in routine primary care, and without drugs,” said Lean. "We've found that people were really interested in this approach – almost a third of those who were asked to take part in the study agreed. This is much higher than usual acceptance rates for diabetes clinical trials."

The study was funded by Diabetes UK who has committed more than £2.8 million to the DiRECT study. Recently, £300,000 has been committed so participants who wish to continue can be followed for up to three years and the full cost-effectiveness of this programme can be evaluated. The funding will provide further understanding around the long-term benefits, to see if a treatment of this kind could be offered to people with Type 2 diabetes in the future.Helping millions

"These first-year findings of DiRECT demonstrate the potential to transform the lives of millions of people. We're very encouraged by these initial results, and the building robust evidence that remission could be achievable for some people,” said Dr Elizabeth Robertson, Director of Research at Diabetes UK. "The trial is ongoing, so that we can understand the long-term effects of an approach like this. It's very important that anyone living with Type 2 diabetes considering losing weight in this way seeks support and advice from a healthcare professional."

Whether putting Type 2 diabetes into remission can protect against diabetes-related complications later in life is not yet known, which is why it is important that those who achieve remission continue to receive health checks. More research is also needed to find out who could benefit most from treatments like this in the future, taking into account factors like ethnicity and duration of Type 2 diabetes. 

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