OR19-08 Intermittent versus Time-Restricted or Continuous Calorie Restriction for the Management of Obesity with Type 2 Diabetes: A Randomized Clinical Trial

Abstract Disclosure: H. Zhang: None. Z. Zhu: None. B. Qiao: None. W. Li: None. M. Wu: None. Background and Objective: 5:2 intermittent fasting has shown promise as an effective strategy for blood glucose control and weight management, but direct evidence comparing it to 10-hour time-restricted eating (TRE) in individuals with obesity and type 2 diabetes remains limited. This study aims to compare the effects of intermittent energy restriction (IER), TRE and continuous energy restriction (CER) on blood glucose and body weight in patients with obesity and type 2 diabetes. Materials and Methods: This study was a single-center, randomized, parallel-controlled trial conducted at the First Affiliated Hospital of Zhengzhou University from November 19, 2021 to November 7, 2024. A total of 90 eligible patients were randomly assigned in a 1:1:1 ratio to the IER, TRE or CER group, with consistent weekly caloric intake across all three groups. The interventions were supervised and guided by a nutritionist over 16 weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) levels, while secondary endpoints included blood glucose, insulin sensitivity, blood lipids, uric acid, liver enzymes, adverse event incidence and patient adherence (actual compliance with intervention frequency/theoretical frequency of dietary intervention). Results: A total of 63 patients completed the 16-week intervention (18 females, 45 males, average age 36.8 years, average disease duration 1.5 years, baseline body mass index 31.7 kg/m², HbA1c 7.42%). At the end of the 16-week intervention, there were no significant differences in HbA1c reduction (-1.56% vs -1.44% vs -1.03%, P = 0.23) and weight loss (-8.6 kg vs -8.2 kg vs -5.7 kg, P = 0.39) between the IER, TRE and CER groups, although the absolute decrease in HbA1c and body weight was greatest in the IER group. Compared to TRE and CER, IER significantly reduced fasting blood glucose (-2.3 mmol/L [SD 1.51 mmol/L]) and triglycerides (-1.139 mmol/L [SD 1.335 mmol/L]) and increased the Matsuda index (80.23 [SD 70.69]) (all pairwise comparisons P < 0.05). There were no differences in the reduction of uric acid and liver enzymes from baseline among the three groups. Hypoglycemia occurred in 2 patients in the IER group, 2 patients in the TRE group, and 3 patients in the CER group. In terms of patient adherence, the IER group had the highest adherence rate (85%), followed by the CER group at 84% and the TRE group at 78%. Statistically significant differences were observed between the IER and CER groups versus the TRE group (P<0.05). Conclusion and Significance: IER, TRE and CER all effectively improved HbA1c levels in patients with obesity and type 2 diabetes. The incidence of adverse events was similar across the three groups. However, IER demonstrated greater advantages in reducing fasting blood glucose, improving insulin sensitivity, lowering triglycerides and enhancing patient adherence. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2100052582 Presentation: Sunday, July 13, 2025