Title : Remission of type 2 diabetes by diet treatment: The UK diabetes remission clinical trial (DiRECT)
Background: Type 2 diabetes has usually been considered a chronic progressive disorder that requires lifelong treatment. The DiRECT trial was designed assess remissions over two years using a dietary weight-management programme.
Methods: DiRECT is an open-label, cluster-randomised controlled trial in UK primary care practices assigned to provide either a weight management programme (intervention) or usual best-practice care (control). We recruited people aged 20–65 years, diagnosed with type 2 diabetes for up to 6 years, BMI 27–45 kg/m2, and not receiving insulin. The integrated intervention comprised Total Diet replacement (825–853 kcal/day formula diet) for 3–5 months, stepped food reintroduction (2–8 weeks), and structured support for weight loss maintenance, with 20-30 minute appointments with a trained local dietitian or nurse. All anti-diabetes drugs and antihypertensive drugs were stopped at the start, and reintroduced in necessary later. Remission of diabetes was defined as HbA1c <6•5%, <48 mmol/mol on no anti-diabetes medications. SRCTN registry, number 03267836.
Findings: Primary outcome data were available on all 149 participants in each group in each group from baseline to 24 months. At 12 months, with a mean weight loss of about 10kg, 46% of patients in the intervention group were in remission. Overall, 86% of participants who lost >15kg, and 73% of those who lost >10kg, no longer had diabetes. The cost of providing the intervention programme is under half the average healthcare cost of continuing to treat the diabetes conventionally. Cardiovascular risk factors and quality of life all improved. Results at 24 months, to be announced 8th March 2019, will be presented.
Conclusion: Type 2 diabetes is a disease of ectopic fat accumulation and not necessarily permanent. Remission of type 2 diabetes is a practical and important treatment target. A structured weight management can sustain remission to a nondiabetic state, with great personal benefits.