by Lewis Chang, PhD
One-year results from a new long-term clinical trial demonstrate that, compared with the usual guideline-based care, a more aggressive weight management program implemented at primary care practices can effectively help patients achieve type 2 diabetes (T2D) remission .
Researchers from Newcastle University (Newcastle City, UK) and University of Glasgow (City of Glasgow, UK) conducted a cluster-randomized trial (Diabetes Remission Clinical Trial, or DiRECT) at 49 primary care practices in Scotland and Northeast region of England. A total of 306 patients with T2D aged 20-65 years and BMI of 27-45 who were not receiving insulin were recruited. The objective was to compare the efficacy of a weight management program (intervention) against best-practice care by guidelines (control). The intervention comprised:
- A low-calorie diet providing 825-853 kcal/day for 3-5 months. Patients could either purchase a liquid diet plan or choose their own food using a calorie counting app. Fiber supplement and multi-vitamin supplement were added to the diet
- Stepped meal re-introduction to normal food for 2-8 weeks
- Structured support for long-term weight loss maintenance, including a diet around 1400 kcal/day and cognitive behavioral therapy
- Withdrawal of antidiabetic and antihypertensive drugs
The one-year data showed that the average weight loss was 10 kg (22 lb) in the intervention group compared to just 1 kg (2.2 lb) in the control group. Nearly one quarter of participants in the intervention group lost 15 kg (33 lb) or more of total body weight vs none in the control group. On average, 46% of participants in the intervention group and 4% of participants in the control group achieved T2D remission (defined as HbA1c < 6.5). Remission was achieve in 86% of those who lost 15 kg or more. Quality of life, as assessed by the EuroQol 5 Dimensions visual analogue scale, improved by 7.2 points in the intervention group and decreased by 2.9 points in the control group. Few serious adverse events were documented in both groups and no adverse events led to withdrawal from the study.
The researchers and patients were very encouraged by the one-year results. The trial is still ongoing and its long-term efficacy and safety will be assessed at 2 years and 3 years.
The study results were published in the journal Lancet (December 2017).
Why is this Clinically Relevant?
- T2D requires lifelong lifestyle intervention. These results demonstrate that clinician-supervised weight management program conducted by primary care practices can lead to successful T2D remission within months
 Lean, M.E., et al., Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet, 2017 pii: S0140-6736(17)33102-1.