5-year follow-up of the randomised Diabetes Remission Clinical Trial (DiRECT) of continued support for weight loss maintenance in the UK: an extension study
An erratum to this article was published (Lancet Diabetes Endocrinol, Jun 2024 ↗)
Authors' conclusion
The extended DiRECT intervention was associated with greater aggregated and absolute weight loss, and suggested improved health status over 5 years.
Study context
- Population
- Adults aged 20–65 years with T2D <6 years, BMI >27 kg/m², not on insulin; UK primary care practices
- Participants
- 95 / 54 / 149 / 149
- Comparison
- Continued low-intensity dietary support (DiRECT extension) vs intervention withdrawn (non-extension); original intervention vs control
- DiRECT extensionn = 95
- Non-extensionn = 54reference
- Original interventionn = 149
- Controln = 149reference
- Primary endpoint
- Remission of T2D
- Follow-up
- Up to 5 years
Methodological details5-year follow-up, primary care, UK
- 5-year follow-up
- Primary care
- UK
Primary result
As reported in the abstract
Visits in remission
34% vs 12%
P < 0.0001
DiRECT extension vs Non-extension
Visits in remission
27% vs 4%
P < 0.0001
Original intervention vs Control
Further findings
Mean, kg
| Outcome | DiRECT extension | Control | Estimate | P value |
|---|---|---|---|---|
| Weight loss · up to 5 years | 6.1 | 4.6 | ||
| Visits with HbA1c <48 mmol/mol (<6.5%) · up to 5 yearsDiRECT extension vs Non-extension | 36% vs 17% | P = 0.0004 | ||
| Visits with HbA1c <48 mmol/mol (<6.5%) · up to 5 yearsOriginal intervention vs Control | 29% vs 15% | P = 0.0002 | ||
| Visits without glucose-lowering medication · up to 5 yearsDiRECT extension vs Non-extension | 62% vs 30% | P < 0.0001 | ||
| Visits without glucose-lowering medication · up to 5 yearsOriginal intervention vs Control | 51% vs 16% | P < 0.0001 | ||
| Visits with weight >5% below baseline · up to 5 yearsOriginal intervention vs Control | 61% vs 29% | P < 0.0001 |
- Weight loss: control weight loss n=82
Remission at 5 years among those in remission at year 2
- Remained in remission
- 26%
Safety
| Outcome | Original intervention | Control | P value |
|---|---|---|---|
| Serious adverse eventsOriginal intervention vs Control | 4.8 events per 100 patient-years | 10.2 per 100 patient-years | P = 0.0080 |
Original publication
5-year follow-up of the randomised Diabetes Remission Clinical Trial (DiRECT) of continued support for weight loss maintenance in the UK: an extension study. Lancet Diabetes Endocrinol. Published 26 February 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →