Extension study from DIRECT showed ongoing remission rate from type 2 diabetes in some patient following very low calorie diet at 5 years

Previous experimental study have shown that very low calorie Diet (VLCD)¹ can induced remission from type 2 diabetes by reduction in fat contents in the pancreas and in the liver. Since then, the DIRECT study has shown that remission from type 2 diabetes can be translated into clinical practice in selected patients.² In that study, which started in 2014 and ran for 2 years, 46% of people with type 2 diabetes who received the weight management programme were in remission 1 year later, and 36% at 2 years. Ongoing debate therefore persists regarding long-term efficacy of VLCD as means to induce long-term remission from type 2 diabetes.

Results from a three-year extension of the landmark DIRECT study published in Lancet Diabetes & Endocrinology³ have now shown that it is possible to stay in remission of type 2 diabetes for at least 5 years. However, the study also finds that maintaining weight loss and staying in remission can be challenging. This new study showed that 13% of people who had received the weight management programme and continued to have support through the extension study were in remission of type 2 diabetes at 5 years.

In this extension study, participants from the original DiRECT study were followed up for a further 3 years. Some participants from the original intervention group opted to continue to receive support and advice from their GP surgery to help them maintain weight loss over the next 3 years. Anyone who regained more than 2 kg during the 3 years was offered an additional package of support. This consisted of the low-calorie ‘soups and shakes’ diet for 4 weeks and support to reintroduce normal meals.

At year five, remission data was available for 93 people from the original control group and 118 people from the original intervention group (including the 85 people who had continued to receive support from their GP during years 3–5). The study showed that 12 out of 118 (10%) in the intervention group were still in remission at year five, compared to 5 out of 93 (5%) in the control group. In the intervention group, of the 85 who had continued to receive support from their GP, 11 (13%) were still in remission. At year five, the average weight loss in the intervention group was 5.6 kg compared with 4.6 kg in the control group. Weight loss was greater in the intervention group who continued to receive GP support—average weight loss of 6.1 kg but those who remained in remission had greater weight loss at 8.9 kg. Over the whole 5-year study period, people in the intervention group spent on average 27% of the time in remission compared to 4% in the control group. The intervention group also spent more time with their body weight lower than baseline, off blood sugar lowering medications and with blood sugar levels in the non-diabetes range than the control group.

The study therefore showed that while some people could stay in remission for 5 years, many patients were not able to maintain diabetes remission. However, a previous study have also shown that even a brief period of diabetes remission is still associated with long-term cardio-metabolic benefits.⁴ The present study also showed that maintaining weight loss is an important component of maintaining diabetes remission.

The DiRECT study has led to the National Health Service to implement the Type 2 Diabetes Path to Remission Programme across England. Based on this latest extension study, further research is needed to understand how best to support people with type 2 diabetes to maintain weight loss and remission over time, as well as strategies to preserve loss of lean muscle mass.