A 5:2 Intermittent Fasting Meal Replacement Diet and Glycemic Control for Adults With Diabetes: The EARLY Randomized Clinical Trial.
JAMA Netw Open
; 7(6): e2416786, 2024 Jun 03.
Article
in En
| MEDLINE
| ID: mdl-38904963
ABSTRACT
Importance An intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet (52 MR) could provide additional benefits to patients with type 2 diabetes. Objective:
To evaluate the effect of the 52 MR on glycemic control among patients with early type 2 diabetes compared with metformin and empagliflozin. Design, Setting, andParticipants:
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 111 ratio to receive either metformin, empagliflozin, or 52 MR. The treatment was 16 weeks, with an 8-week follow-up. Main Outcomes andMeasures:
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 52 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 52 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 52 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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Benzhydryl Compounds
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Fasting
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Diabetes Mellitus, Type 2
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Glycemic Control
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Glucosides
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Metformin
Limits:
Adult
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Female
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Humans
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Male
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Middle aged
Country/Region as subject:
Asia
Language:
En
Journal:
JAMA Netw Open
Year:
2024
Document type:
Article
Affiliation country:
China