Diet and Diabetes Remission (DIREM): Effects of Calorie-carbohydrate Restriction versus Intermittent Fasting for Type 2 Diabetes Remission: Study Protocol for a Randomized Controlled Trial

Abstract Introduction: Diabetes is a devastating chronic disease with a high prevalence worldwide, one of the main causes of which is obesity. There is growing evidence that type 2 diabetes remission is possible through significant weight loss. Diet and Diabetes Remission (DIREM) aims to investigate the effect of comprehensive lifestyle intervention on diabetes remission by comparing two diets of calorie-carbohydrate restriction (CCRs) versus the combination of intermittent fasting diet with calorie-carbohydrate restriction (IFCCR). Methods: DIREM is a parallel randomized and controlled clinical trial that compares cost-effectiveness, cost-utility, and the clinical effects of two CCR and IFCCR diets on body composition and diabetes remission in patients with type 2 diabetes aged 18–60 years, with < 5-year duration of diabetes diagnosis and body mass index 27–40 kg/m 2 . Other key outcomes of interest include glycemic indicators, blood lipid profiles, liver function tests, blood pressure, Quality Adjusted Life Years index per patient, cost per patient, number and cost of medicine, cost-effectiveness, and cost utility. Expected Results: The percentage of remission and average changes in outcomes of the study are different between two dietary intervention groups and control group at 3 and 6 months after the intervention. Conclusion: If the interventions of this study are cost-effective and have positive effects on diabetes remission and the results are confirmed in subsequent studies, these dietary interventions within lifestyle intervention can be recommended as the main treatment approach for type 2 diabetes patients.