Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial.
Level 2 - randomized trial
Individual cluster-randomized controlled trial
PubMed 30852132 · doi:10.1016/S2213-8587(19)30068-3
What was done
In an open-label cluster-randomized trial across UK primary care practices, 298 adults aged 20–65 with type 2 diabetes duration under 6 years, BMI 27–45 kg/m², and not on insulin were allocated 1:1 by practice to a structured weight-management program or best-practice guideline care (149 per group). The intervention comprised initial withdrawal of antidiabetes and antihypertensive medications, total diet replacement (825–853 kcal/day formula diet for 12–20 weeks), stepped food reintroduction (2–8 weeks), and structured maintenance support. Coprimary outcomes at 24 months analyzed by intention-to-treat were weight loss of at least 15 kg and diabetes remission (HbA1c <6.5% [48 mmol/mol] without antidiabetes drugs).
What was found
At 24 months, weight loss of at least 15 kg was achieved by 17 (11%) intervention participants versus 3 (2%) controls (adjusted odds ratio [aOR] 7.49, 95% CI 2.05 to 27.32; p=0.0023). Diabetes remission was maintained in 53 (36%) intervention participants versus 5 (3%) controls (aOR 25.82, 95% CI 8.25 to 80.84; p<0.0001). Adjusted mean differences between groups were -5.4 kg (95% CI -6.9 to -4.0; p<0.0001) for bodyweight and -4.8 mmol/mol (-0.44%, 95% CI -8.3 to -1.4; p=0.0063) for HbA1c. Antidiabetes medication was used by 51 (40%) of 129 intervention patients versus 120 (84%) of 143 control patients. In post-hoc analysis, 29 of 45 participants (64%) who sustained >=10 kg weight loss achieved remission. Serious adverse events were fewer in the intervention group in year 2 (9 vs 22).
Why it matters
This study shows that intensive dietary weight management delivered in routine primary care can achieve sustained type 2 diabetes remission off medication at 2 years in over a third of patients.
Limits
The trial was open-label, with participants and providers aware of allocation. The sample was restricted to individuals with diabetes duration under 6 years who were not on insulin, limiting generalizability to longer-standing disease. Weight regain was notable between years 1 and 2, with the proportion achieving >=15 kg weight loss falling from 24% to 11%.
Cited by
- partial Adopting healthy lifestyle habits such as diet, exercise, and proper sleep can reverse diabetes.