medwireNews: Just over a third of people who undertook a period on a very-low-calorie diet in the DiRECT trial to tackle type 2 diabetes are in remission 24 months later, the investigators have reported.
The team previously found that 46% of the 149 participants in the intervention group had remission of type 2 diabetes at the 12-month follow-up. The proportion still in remission at 24 months is 36%, they revealed today at the Diabetes UK Professional Conference in Liverpool.
By contrast, just 3% of the 149 people in the control group, who continued to receive standard medical care, were in remission at 24 months, defined as having glycated hemoglobin levels below 6.5% (48 mmol/mol) without using any antidiabetic medications.
However, there was some weight regain during the second year of the trial, with the intervention group regaining an average of 2.6 kg, whereas the control group lost an average of 1.3 kg. Participants who had been in remission but relapsed regained more weight than those who remained in remission, at 7.1 versus 4.3 kg.
Also, around half of the 143 intervention group participants with relevant data available had needed to resume the study diet at least once during the 2-year follow-up to combat weight regain, and 2% were taking orlistat by the end of the study.
All study participants had been diagnosed with type 2 diabetes within 6 years before enrolment, and were overweight or obese. Those in the intervention group stopped all diabetes medications and started a diet of 825–853 kcal/day for at least 3 months, with the aim of losing at least 15 kg.
This endpoint was achieved by 24% of the intervention group at 12 months and by 11% at 24 months. No one in the control group had lost this amount of weight at 12 months, but 2% had done so by 24 months.
The proportion of people who were in remission at 24 months rose with the amount of weight lost, from 5.2% of those who lost less than 5 kg to 70.0% of those who lost 15 kg or more.
In line with the weight loss findings, the DiRECT Mechanistic Study showed that, among the 40 people who achieved diabetes remission with the diet intervention, the 13 who relapsed during the following 2 years had rising levels of liver fat, export of very-low-density-lipoprotein–triglyceride from the liver, and pancreatic fat compared with the 49 who remained in remission.
This followed marked reductions in these parameters as a result of the diet intervention and, overall, is consistent with the “Twin Cycle” mechanism, underpinned by the accumulation of liver fat resulting from excess calorie consumption.
The findings have been simultaneously published in The Lancet Diabetes & Endocrinology, in which Paul Aveyard (University of Oxford, UK) and co-authors of an accompanying commentary suggest that the DiRECT results might apply more widely, such as to people with a longer duration of diabetes, and that even greater weight loss could further increase the chances of diabetes remission.
They do however outline a number of other questions remaining to be addressed, including the definition of diabetes remission, the optimal program for achieving weight loss in clinical practice, and the intensity and duration of ongoing support required and whether this can be achieved in clinical practice.
Nevertheless, they conclude that “DiRECT should change the paradigm—remission from type 2 diabetes is possible with support from generalist clinicians.”
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