A 5:2 Intermittent Fasting Meal Replacement Diet and Glycemic Control for Adults With Diabetes: The EARLY Randomized Clinical Trial
Authors' conclusion
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.
Study context
- Population
- Chinese adults with overweight or obesity and early T2D, 9 centers in China; 65.4% men, mean age 45.5 years, mean BMI 29.5, mean hemoglobin A1c (HbA1c) 7.9%332 completed
- Participants
- 405 adults
- Comparison
- 5:2 intermittent fasting meal replacement diet (5:2 MR) vs metformin vs empagliflozin
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- 16 weeks
Methodological detailsopen-label, active parallel-controlled, multicentre (9 centers, China), Treatment 16 weeks with 8-week follow-up; randomized 1:1:1
- Open-label
- Active parallel-controlled
- Multicentre (9 centers, China)
- Treatment 16 weeks with 8-week follow-up; randomized 1:1:1
Primary result
As reported in the abstract
Change in HbA1c · baseline to week 16
5:2 MR
−1.9
least-squares mean · SE 0.2% · %
Metformin
−1.6
least-squares mean · SE 0.2% · %
Empagliflozin
−1.5
least-squares mean · SE 0.2% · %
Adjusted LSM difference, % (95% CI)
5:2 MRvs Metformin
−0.3(−0.4% to −0.1%)
5:2 MRvs Empagliflozin
−0.4(−0.6% to −0.2%)
Secondary outcomes
Least-squares mean, kg
| Outcome | 5:2 MR | Metformin | Empagliflozin |
|---|---|---|---|
| Weight change · week 16 | −9.7 (SE 2.2 kg) | −5.5 (SE 2.3 kg) | −5.8 (SE 2.3 kg) |
Weight change · week 16
- Weight loss greater with 5:2 MR than metformin and empagliflozin
Original publication
A 5:2 Intermittent Fasting Meal Replacement Diet and Glycemic Control for Adults With Diabetes: The EARLY Randomized Clinical Trial. JAMA Netw Open. Published 3 June 2024. doi:10.
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