A 5:2 Intermittent Fasting Meal Replacement Diet and Glycemic Control for Adults With Diabetes

Author:

Guo Lixin1,Xi Yue2,Jin Wenbo3,Yuan Huijuan4,Qin Guijun5,Chen Shuchun6,Zhang Lihui7,Liu Yu8,Cheng Xingbo9,Liu Wen10,Yu Dongni1

Affiliation:

1. Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China

2. Department of Endocrinology, The Third Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China

3. Department of Endocrinology, Nanyang Central Hospital, Nanyang, Henan, China

4. Department of Endocrinology, Henan Provincial People’s Hospital, Zhengzhou, Henan, China

5. Department of Endocrinology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

6. Department of Endocrinology, Hebei Provincial People’s Hospital, Shijiazhuang, Hebei, China

7. Department of Endocrinology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

8. Department of Endocrinology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, China

9. Department of Endocrinology, The First Affiliated Hospital of Soochow University, Soochow, Jiangsu, China

10. Department of Clinical Nutrition, Beijing Tongren Hospital, Capital Medical University, Beijing, China

Abstract

ImportanceAn intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet (5:2 MR) could provide additional benefits to patients with type 2 diabetes.ObjectiveTo evaluate the effect of the 5:2 MR on glycemic control among patients with early type 2 diabetes compared with metformin and empagliflozin.Design, Setting, and ParticipantsThe EARLY (Exploration of Treatment of Newly Diagnosed Overweight/Obese Type 2 Diabetes Mellitus) study is a randomized, open-label, active parallel-controlled clinical trial conducted between November 13, 2020, and December 29, 2022, in 9 centers across China. A total of 509 eligible patients underwent screening, out of which 405 were randomly assigned to 3 groups and included in the intention-to-treat analysis.InterventionsPatients were randomly allocated in a 1:1:1 ratio to receive either metformin, empagliflozin, or 5:2 MR. The treatment was 16 weeks, with an 8-week follow-up.Main Outcomes and MeasuresThe primary end point was the change in hemoglobin A1c (HbA1c) level from baseline to 16 weeks. Secondary end points included changes in body weight, anthropometric measurements, and biochemical parameters.ResultsOf the 405 randomized participants (265 men [65.4%]; mean [SD] age, 45.5 [11.0] years; mean [SD] body mass index, 29.5 [4.1]; and mean [SD] HbA1c level, 7.9% [0.6%]), 332 completed the 16-week treatment. From baseline to week 16, participants in the 5:2 MR group showed the greatest reduction in HbA1c (least-squares mean [LSM], −1.9% [SE, 0.2%]), significantly greater than patients receiving metformin (LSM, −1.6% [SE, 0.2%]; adjusted LSM difference, −0.3% [95% CI, −0.4% to −0.1%]) and empagliflozin (LSM, −1.5% [SE, 0.2%]; adjusted LSM difference, −0.4% [95% CI, −0.6% to −0.2%]). At week 16, the mean weight loss in the 5:2 MR group (LSM, −9.7 kg [SE, 2.2 kg]) was greater than that in the metformin group (LSM, −5.5 kg [SE, 2.3 kg]) and empagliflozin group (LSM, −5.8 kg [SE, 2.3 kg]).Conclusions and RelevanceThis randomized clinical trial of Chinese adults with overweight or obesity and with early type 2 diabetes found that 5:2 MR could improve glycemic outcomes and weight loss in the short term compared with metformin or empagliflozin, making it a promising initial intervention and early management for type 2 diabetes.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR2000040656

Publisher

American Medical Association (AMA)

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