The Effect of Integrated Lifestyle Intervention Incorporating Calorie‐Carbohydrate Restriction With or Without Time‐Restricted Feeding for Remission of Type 2 Diabetes ( DIREM ): A Single Blind Randomised Controlled Trial

AIMS: We conducted the diet and diabetes remission (DIREM) study to assess whether an integrated lifestyle intervention would lead to achieving remission in type 2 diabetes. MATERIALS AND METHODS: Patients with type 2 diabetes were randomly assigned to calorie-carbohydrate restriction (CCR) group, intermittent fasting with calorie-carbohydrate restriction (IFCCR), or usual care group (control). The total study duration was 6 months, consisting of two phases: a 12-week integrated lifestyle intervention (ILI) phase, followed by a 12-week maintenance and structured monitoring (MSM) phase. The intervention was presented in the form of a structured behavioural model and also emphasised physical activity. RESULTS: One hundred and twenty participants were randomly assigned to the study. Diabetes remission occurred in 9 (22.5%) of 40 participants in the CCR group (OR (CCR vs. Control) = 11.7, 95% CI: 1.4-98.3; p = 0.024), 12 (30.0%) of 40 participants in the IFCCR group (OR (IFCCR vs. Control) = 18.1, 95% CI: 2.2-151.0; p = 0.007) and 1 (2.5%) of 40 participants in the control group. The odds of remission were higher in the IFCCR group compared to the CCR group, but it was not significant (OR (IFCCR vs. CCR) = 1.5, 95% CI: 0.6-4.3; p = 0.4). CONCLUSIONS: Both calorie-carbohydrate restriction alone and in combination with intermittent fasting significantly improved glycemic control and induced diabetes remission compared with the control group. No significant difference was found between the two interventions. Larger long-term studies are needed to confirm these findings. TRIAL REGISTRATION: This trial was registered in the Iranian Registry of Clinical Trials (IRCT), IRCT20240418061519N1 (https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20240418061519N1).