A 5:2 Intermittent Fasting Meal Replacement Diet and Glycemic Control for Adults With Diabetes: The EARLY Randomized Clinical Trial
Guo L, Xi Y, Jin W, Yuan H, Qin G, Chen S, Zhang L, Liu Y, Cheng X, Liu W, Yu D
JAMA network open · 43 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2024-06-21 · JAMA Netw Open · vol. 7 · issue 6 · p. e2416786
- Publisher
- American Medical Association
- Cited
- 58 citations · more than 99% of similar papers · 13.0× the field average
- Impact
- Top 10% most cited in its field
- References
- 40 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Dietary Effects on Health · Diet and metabolism studies · Genetics, Aging, and Longevity in Model Organisms
- Keywords
- Medicine, Glycemic, Overweight, Body mass index, Type 2 diabetes, Diabetes mellitus, Metformin, Randomized controlled trial, Internal medicine, Clinical endpoint, Weight loss, Hemoglobin A, Intermittent fasting, Obesity, Physical therapy, Endocrinology
- MeSH
- humans, diabetes mellitus, type 2, metformin, benzhydryl compounds, glucosides, blood glucose, hypoglycemic agents, fasting, adult, middle aged, china, female, male, glycemic control, glycated hemoglobin, intermittent fasting
11 authors
From CN
- Lixin Guo · correspondingChinese Academy of Medical Sciences & Peking Union Medical College
- Yue XiJinzhou Medical University
- Jin WenboNanyang Institute of Technology
- Huijuan YuanHenan Provincial People's Hospital
- Guijun QinFirst Affiliated Hospital of Zhengzhou University
- Shuchun ChenHospital of Hebei Province
Abstract
Importance
An 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.
Objective
To 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 participants
The 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.
Interventions
Patients 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 measures
The 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.
Results
Of 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 relevance
This 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 registration
Chinese Clinical Trial Registry Identifier: ChiCTR2000040656.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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