Summary: In 56 adults with type 2 diabetes, overweight or obesity, and high risk of an eating disorder in England, a remotely delivered low-energy total diet replacement (TDR) programme with behavioural support was non-inferior to usual care for eating disorder symptoms at 6 months (EDE-Q between-group difference -0.8 points, 95% CI -1.4 to -0.3; margin +0.72). Weight loss was greater with the programme (-13.9 kg vs -3.7 kg; between-group -10.2 kg, 95% CI -14.2 to -6.2), and no participant was suspected of developing an eating disorder.
PICO Summary
| Element | Detail |
|---|---|
| Population | 56 adults (mean age 49.9 years; 63% women) with type 2 diabetes, overweight or obesity (mean BMI 39.6 kg/m2), and high eating-disorder risk (mean EDE-Q global score 3.3) across England. Randomised, controlled, non-inferiority trial (NCT05744232). |
| Intervention | 12-week remotely delivered low-energy total diet replacement (formula soups, shakes, bars) with behavioural support, followed by ~8 weeks of food reintroduction and ~4 weeks of weight maintenance advice (n=28). |
| Comparison | Usual care for type 2 diabetes (n=28). |
| Outcome | Primary: change in EDE-Q global score at 6 months; between-group difference -0.8 points (95% CI -1.4 to -0.3), within the pre-specified non-inferiority margin of +0.72, indicating non-inferiority. Weight loss at 6 months -13.9 kg (intervention) vs -3.7 kg (control); between-group -10.2 kg (95% CI -14.2 to -6.2). At 12 months weight change did not differ between groups, while EDE-Q non-inferiority and superiority persisted. No participant was suspected of developing a new eating disorder; 13 adverse events occurred, one serious (cholecystectomy). HbA1c was not reported in the abstract. |
ARIADNE trial
Non-inferiority RCT · type 2 diabetes · 6 months
A supported low-energy total diet replacement programme did not worsen eating disorder symptoms versus usual care and produced markedly greater 6-month weight loss in high-risk adults with type 2 diabetes.
Expert Commentary
This non-inferiority trial was designed to test a safety question, not to prove glycaemic efficacy, and on that question the result is reassuring. In a population deliberately selected for elevated eating-disorder risk, a supported low-energy total diet replacement programme did not worsen EDE-Q symptoms relative to usual care, and the point estimate actually favoured the intervention. No participant was suspected of developing a new eating disorder, and substantial early weight loss was achieved. The principal limitation is scale and fragility: only 56 participants were randomised, the cohort was 96% White, and the convergence of weight outcomes by 12 months suggests the metabolic benefit may not be durable without continued support. Confidence intervals are correspondingly wide, and a small trial cannot exclude rare harms. Sponsorship by the Novo Nordisk UK Research Foundation, a manufacturer with a commercial interest in obesity care, warrants noting, as does the open, unblinded delivery inherent to a dietary intervention. Can I use this with my patients? Cautiously yes, for a closely monitored adult with type 2 diabetes and screened eating-disorder risk who is considering a structured TDR programme, provided behavioural support and eating-disorder surveillance are built in. Clinicians should regard this as encouraging evidence against a feared harm rather than a mandate, and a larger, more diverse confirmatory trial would be welcome before broad adoption.
References
Tsompanaki E, Aveyard P, Park RJ, Jebb SA, Koutoukidis DA. An intensive weight loss programme with behavioural support for people with type 2 diabetes at risk of eating disorders in England (ARIADNE): a randomised, controlled, non-inferiority trial. Lancet Psychiatry. 2025;12(7):483-492. doi:10.1016/S2215-0366(25)00126-9