A reversal of type 2 diabetes (T2D) may be possible with low-calorie liquid diet for up to 5 months, increased physical activity, and cognitive behavioural therapy, preliminary results of the DiRECT* trial has shown.

“This was a clinical trial driven largely by the patients’ will and the response was very positive,” said lead author Professor Michael Lean from the University of Glasgow in Scotland at the recent IDF Congress 2017. “Our findings suggest that even if you have had T2D for 6 years, putting the disease into remission is feasible.”

The open-label randomized DiRECT trial included 250 patients (age 20-65 years) in the UK who had T2D for 6 years and were not on insulin. Half of the patients were treated using normal diabetes treatment, including medications, and weight-loss counselling while the other half were withdrawn of their antidiabetic and antihypertensive drugs and given a low calorie, liquid diet (no more than 825–853 kcal/day for 3 to 5 months), followed by gradual food reintroduction (over 2–8 weeks), and a structured support programme for long-term weight-loss maintenance, including cognitive behaviour therapy and exercise. [Lancet 2017;doi: 10.1016/S0140-6736(17)33102-1]

At 1 year, diabetes remission (HbA_1c <6.5 percent after 2 months off antidiabetic medications) for up to 12 months was achieved by almost half of the patients in the intervention group (68 patients, 46 percent) and six (4 percent) in the control group (odds ratio [OR], 19.7; p<0.0001). Mean body weight dropped by 10 kg in the intervention group and 1 kg in the control group (p<0.0001).

Thirty-six patients in the intervention group achieved the primary outcome of >15 kg weight loss and diabetes remission vs zero in the control group (p<0.0001).

Overall, one patient experienced biliary colic and abdominal pain but still continued in the study. Others had constipation, headache, and dizziness but still persisted, said Lean. The trial is set to continue for 2 more years.

“The diagnosis of T2D is a medical emergency that needs action. Hopefully, this is a watershed in the understanding and management of the disease,” said lead author Professor Roy Taylor from the Newcastle University, UK. “Short-duration T2D can be put into remission by primary care staff using a structured programme.”

The researchers said the study is a bit controversial and different from previous studies as it was conducted in a real-life setting, with nurses or dietitians delivering the weight-loss regimen. What is also interesting is that it appeared to be the only study to date with T2D remission as the primary outcome.

“These results are impressive and strongly support the view that T2D is tightly associated with an excessive fat mass in the body,” said Prof Matti Uusitupa from the University of Eastern Finland, Kuopio, in an accompanying editorial. “[T]he time of diabetes diagnosis is the best point to start weight reduction and lifestyle changes because the motivation of the patient is usually high …” [Lancet 2017;doi:10.1016/S0140-6736(17)33100-8]

It is easy to lose weight but difficult to maintain weight loss. The bigger challenge is how to avoid weight rebound in the long term, added Lean. The ongoing DiRECT trial will seek to determine if weight loss and remission are achievable in the long term.