DiRECT trial: Diabetes remission achievable in primary care
medwireNews: Nearly half of the patients helped to follow a very-low-calorie diet for at least 3 months achieved and maintained remission of type 2 diabetes over the 12 months of the DiRECT trial, the investigators report.
“The present study differs importantly from most previous ones in that it was done under real-life conditions, delivered by the available local nurses or dietitians rather than by specialist staff,” say Roy Taylor (Newcastle University, UK) and co-researchers.
They also note that they enrolled “a greater proportion of men than normally seen in weight loss trials,” with men comprising around 60% of participants.
Patients from primary care practices who were randomly assigned to the intervention discontinued all oral antidiabetic agents and antihypertensive medications on the first day of the diet. Diabetes remission, which occurred in 46% of 149 patients initially assigned to the intervention, was defined as having glycated hemoglobin (HbA1c) levels below 6.5% (48 mmol/mol) without using any antidiabetic medications.
By contrast, just six (4%) of the 149 patients who continued to receive usual care achieved diabetes remission.
All trial participants had been diagnosed with diabetes within the preceding 6 years, with the average time since diagnosis being 3 years. Around three-quarters of all patients were taking at least one oral antidiabetic agent at baseline, but average HbA1c levels were 7.7% and 7.5% in the intervention and control groups, respectively.
The patients undertook a low-energy formula diet (825–853 kcal/day) for at least 3 months, and for up to 5 months if they wished, with the aim of losing 15 kg. This co-primary endpoint was achieved by 24% of patients in the intervention group versus none in the control group; baseline BMIs were a respective 35.1 and 34.2 kg/m2.
After the low-energy diet phase, there was a structured food reintroduction phase, lasting 2–8 weeks, followed by monthly visits for weight loss maintenance, with short rescue plans to combat weight gain implemented if and when needed. During these latter two phases, participants were encouraged to increase their physical activity, although the researchers found this to be largely unsuccessful.
Most (83%) participants completed the full 12 months of the trial, with 15 withdrawing during the low-energy diet phase, six during food reintroduction, and five during the maintenance phase. Those who attempted the diet phase lost an average of 14.5 kg during its course, and regained an average of 1.0 kg during the food reintroduction phase and 1.9 kg during the maintenance phase.
The researchers note in The Lancet Diabetes & Endocrinology that they plan to follow up the study participants for at least another 3 years, to gauge the long-term success of the intervention.
The likelihood of achieving diabetes remission rose by 32% per additional kg of weight lost. In all, 7% of patients who lost less than 5 kg achieved remission, rising to 34%, 57%, and 86% of those who lost 5–10, 10–15, and 15 or more kg, respectively. HbA1c fell by an average 0.9% in the intervention group, while increasing by 0.1% in the control group. Quality of life also improved in the intervention group, but decreased among the controls.
Writing in an accompanying commentary, Matti Uusitupa (University of Eastern Finland, Kuopio) suggests that the DiRECT findings should prompt a shift away from type 2 diabetes treatment algorithms based on medications, and if necessary surgery, towards a non-pharmacological approach.
“[T]he time of diabetes diagnosis is the best point to start weight reduction and lifestyle changes because motivation of a patient is usually high and can be enhanced by the professional health-care providers,” says Uusitupa.
“However, disease prevention should be maintained as the primary goal that requires both individual-level and population-based strategies, including taxation of unhealthy food items to tackle the epidemic of obesity and type 2 diabetes.”
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