Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial.
Level 2 - randomized trial
Cluster-randomised controlled trial
PubMed 29221645 · doi:10.1016/S0140-6736(17)33102-1
What was done
In an open-label cluster-randomised trial (DiRECT) across 49 general practices in Scotland and Tyneside, England, 306 adults aged 20–65 with type 2 diabetes diagnosed within 6 years, BMI 27–45 kg/m², and not on insulin were enrolled (149 per group in the intention-to-treat population). Practices were randomised 1:1 to either routine guideline-based care or an intensive weight management programme. The intervention involved stopping antidiabetic and antihypertensive medications, total diet replacement with an 825–853 kcal/day formula diet for 3–5 months, stepped food reintroduction for 2–8 weeks, and structured maintenance support. Co-primary outcomes at 12 months were weight loss of at least 15 kg and diabetes remission (HbA1c <6.5% [<48 mmol/mol] off all antidiabetic drugs for at least 2 months).
What was found
At 12 months, weight loss of 15 kg or more occurred in 36 (24%) intervention participants and 0 (0%) control participants (p<0.0001). Diabetes remission was achieved in 68 (46%) intervention participants versus 6 (4%) controls (odds ratio 19.7, 95% CI 7.8–49.8; p<0.0001). Remission scaled with weight loss across the entire cohort: 0% (0/76) among those who gained weight, 7% (6/89) with 0–5 kg loss, 34% (19/56) with 5–10 kg loss, 57% (16/28) with 10–15 kg loss, and 86% (31/36) with ≥15 kg loss. Mean weight dropped by 10.0 kg (SD 8.0) in the intervention group versus 1.0 kg (SD 3.7) in the control group (adjusted difference -8.8 kg, 95% CI -10.3 to -7.3; p<0.0001). Quality of life (EQ-5D visual analogue scale) improved by 7.2 points in the intervention group and fell by 2.9 points in controls (adjusted difference 6.4 points, 95% CI 2.5–10.3; p=0.0012). Serious adverse events occurred in 7 of 157 (4%) intervention participants (9 events) and 2 of 149 (1%) controls (2 events).
Why it matters
This study demonstrates that type 2 diabetes of relatively short duration can be reversed through substantial dietary weight loss delivered entirely within routine primary care settings without surgical intervention.
Limits
The trial was open-label, leaving participants, carers, and outcome-collecting staff unblinded (only the statistician was blinded). Outcomes are reported only through 12 months. Results apply specifically to patients diagnosed within 6 years who are not taking insulin and may not generalize to longer-standing diabetes, insulin-treated individuals, or populations outside the UK primary care context.
Cited by
- partial Adopting healthy lifestyle habits such as diet, exercise, and proper sleep can reverse diabetes.