DIREM Trial: Time-Restricted Feeding And Diabetes Remission

Key Takeaways

• Diabetes remission was observed more often in both active lifestyle arms than with usual care.
• No significant difference was reported between intermittent fasting plus calorie-carbohydrate restriction and calorie-carbohydrate restriction alone.

In the DIREM trial, 6-month diabetes remission was observed in 12 participants assigned to intermittent fasting plus calorie-carbohydrate restriction and in one control participant. Adults with type 2 diabetes were randomized to that combined approach, calorie-carbohydrate restriction alone, or usual care in this three-arm study. Remission was also observed in the calorie-carbohydrate restriction arm, with both active lifestyle strategies ahead of usual care at follow-up.

DIREM was a single-blind randomized controlled trial in adults with type 2 diabetes, with 120 participants assigned evenly across three groups. The randomized arms were calorie-carbohydrate restriction (CCR), intermittent fasting plus calorie-carbohydrate restriction (IFCCR), and usual care, with 40 participants per group. The study lasted 6 months and began with a 12-week integrated lifestyle intervention phase within each randomized assignment. That was followed by a 12-week maintenance and structured monitoring phase within the same trial schedule.

Diabetes remission occurred in 9/40 participants (22.5%) with CCR, 12/40 (30.0%) with IFCCR, and 1/40 (2.5%) with usual care. Against control, the odds ratio was 11.7 for CCR (95% CI 1.4-98.3; p=0.024). Against control, the odds ratio was 18.1 for IFCCR (95% CI 2.2-151.0; p=0.007). These estimates indicated statistically significant differences for each active intervention compared with usual care over the 6-month follow-up period. The between-active-arm comparison showed IFCCR versus CCR OR 1.5 (95% CI 0.6-4.3; p=0.4), indicating no significant difference between the interventions.