ABU DHABI, United Arab Emirates — Patients with type 2 diabetes can reverse the condition if they stick to a very low-calorie liquid diet, of around 850 kcal per day for 3 to 5 months, and then gradually reintroduce food, with ongoing support for maintenance of weight loss that includes strategies to increase physical activity and cognitive behavioral therapy.
This is the message from the 1-year results of the primary-care–led weight management for remission of type 2 diabetes (Diabetes Remission Clinical Trial [DiRECT]) open-label randomized trial, which were reported today here at the International Diabetes Federation (IDF) Congress 2017 and simultaneously published in the Lancet.
This somewhat controversial study, in almost 250 patients who had had type 2 diabetes for up to 6 years, compared an intensive weight-loss regime using a commercial formula (Cambridge Weight Plan) delivered by practice nurses or dieticians who had received approximately 8 hours of training, with standard best practice for weight loss across 49 primary-care practices in the United Kingdom. The trial is set to continue for at least another 2 years.
Diabetes remission was achieved overall at 1 year in almost half, 68 participants (46%) in the intervention group and six (4%) participants in the control group (odds ratio, 19.7; 95% CI 7.8–49.8; P < .0001).
“This was a clinical trial driven largely by the will of patients, the response to it was very positive,” lead author Prof Michael Lean, from the University of Glasgow, Scotland, said in presenting the results here. “Our findings suggest that even if you have had type 2 diabetes for 6 years, putting the disease into remission is feasible.”
Noting that bariatric surgery has long been hailed as a “cure” for diabetes, he added that there has been a suggestion that such procedures “have almost magical qualities, but we show this can be done without surgery.” Bariatric surgery can achieve remission of diabetes in about three-quarters of people, but it is more expensive and risky and is only available to a small number of patients, he added.
Senior author Prof Roy Taylor from Newcastle University, United Kingdom, told meeting attendees: “The diagnosis of type 2 diabetes is a medical emergency that needs…action. Hopefully this is a watershed in the understanding and management of type 2 diabetes. Short-duration type 2 diabetes can be put into remission by primary-care staff using a structured program.”
And the weight-loss goals provided by this program “are achievable for many people,” he stressed.
Study Results Impressive: Diabetes Diagnosis Is Best Time to Reduce Weight
The present study differs in an important manner from most previous ones in that it was done under real-life conditions, delivered by available local nurses or dietitians rather than by specialist staff, the researchers note. Furthermore, no previous registered study has set remission of type 2 diabetes as a primary outcome
Individuals aged 20 to 65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body mass index of 27 to 45 kg/m², and were not receiving insulin, were invited to participate by letter via their primary-care practice.
The intervention (n = 149) comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825–853 kcal/day formula diet for 3 to 5 months; this was a high-carbohydrate, low-fat, and high-protein diet), followed by stepped food reintroduction (over 2–8 weeks), and structured support for long-term weight-loss maintenance. Participants were given guar fiber supplement to help combat constipation and advised to drink plenty of water.
The remaining 149 patients in the control group received best practice care by guideline.
“A major difference from other studies is that we advised a period of dietary weight loss with no increase in physical activity, but during the long-term follow up increased daily activity is important,” Prof Taylor explained.
Meals were reintroduced one at a time, with advice to follow a 50% carbohydrate, 35% fat, and 15% protein diet, and patients were given step counters and encouraged to achieve 15,000 steps per day during this phase.
Overall, one person experienced serious adverse events possibly related to the treatment (biliary colic and abdominal pain) but continued in the trial. Some participants experienced constipation, headache, and dizziness, but all were tolerated by the participants “as no one left the study,” Prof Lean stressed.
The primary outcomes were weight loss of 15 kg or more and remission of diabetes, which was defined as HbA1c level of less than 6.5%, off all medications.
At 1 year, mean body weight fell by 10.0 kg in the intervention group and 1.0 kg in the control group (adjusted difference –8.8 kg; P < .0001).
The primary outcome of weight loss of 15 kg or more was achieved in 36 (24%) participants in the intervention group and no participants in the control group (P < .0001).
As well as the 46% of patients who achieved remission overall in the intervention group, when the analysis was confined to those who lost 10 kg or more, 73% achieved remission of diabetes.
Writing in an accompanying comment, Prof Matti Uusitupa, from the University of Eastern Finland, Kuopio, said: “These results are impressive and strongly support the view that type 2 diabetes is tightly associated with excessive fat mass in the body.”
“The DiRECT study indicates that the 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 healthcare providers,” he adds, noting that 86% of participants in the intervention group and 99% of those in the control group attended the 12-month study assessment.
Results Should Pave Way to Try This Approach, but Weight Maintenance is Key
Asked whether he thought these results would lead to any changes in guidelines, Prof Lean said he doubted it. “One study for 1 year is unlikely to lead to any major changes in guidelines,” although he noted that other interventions for type 2 diabetes have been recommended with lesser evidence.
Therefore, “our results should pave the way for this type of intervention to be considered in the routine care of patients with type 2 diabetes who wish to attain diabetes remission,” he and his coauthors stress.
Prof Uusitupa agrees: “In view of the results of the DiRECT trial, a nonpharmacological approach should be revived,” he writes.
However, Prof Lean and colleagues are also cognizant of the fact that maintenance of weight loss is a key factor of success, and so they appreciate that longer-term results of their trial will be keenly anticipated.
“It’s relatively easy to lose weight, but patients struggle to maintain the weight loss, and there is very little research funding into maintenance,” Prof Lean told the congress.
Prof Taylor said: “The big challenge is long-term avoidance of weight regain. Follow-up of DiRECT will continue for 4 years and reveal whether weight loss and remission are achievable in the long term.”
Prof Uusitupa says: “Long-term results from the study would be extremely important because postintervention weight regain has been reported in most weight-management studies in nondiabetic patients and in patients with type 2 diabetes.”
Lancet. Published online December 5, 2017. Abstract, Editorial
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