Integration of a fasting-mimicking diet programme in primary care for type 2 diabetes reduces the need for medication and improves glycaemic control: a 12-month randomised controlled trial
Authors' conclusion
Integration of a monthly FMD programme in regular primary care for people with type 2 diabetes who use metformin as the only glucose-lowering drug and/or diet for glycaemic control reduces the need for glucose-lowering medication, improves HbA1c despite the reduction in medication use, and appears to be safe in routine clinical practice.
Study context
- Population
- People with T2D using metformin as the only glucose-lowering drug and/or diet, under primary care; age 18–75 years, BMI ≥27 kg/m²
- Participants
- 100 people
- Comparison
- Monthly 5-day fasting-mimicking diet (FMD) cycles as adjunct to regular care vs regular care only
- FMDn = 51
- Controln = 49reference
- Primary endpoint
- Changes in glucose-lowering medication (medication effect score) and HbA1c levels
- Follow-up
- 12 months
Methodological detailsassessor-blinded, 8 FMD and 10 control participants lost to follow-up
- Assessor-blinded
- 8 FMD and 10 control participants lost to follow-up
Primary result
As reported in the abstract
Adjusted estimated treatment effect (medication effect score)
−0.3
95% CI −0.4 to −0.2P < 0.001
Between FMD and Control
Adjusted estimated treatment effect (HbA1c)
−3.2 mmol/mol
95% CI −6.2 to −0.2P = 0.04
Between FMD and Control
Adjusted estimated treatment effect (HbA1c)
−0.3 %
95% CI −0.6 to −0.0P = 0.04
Between FMD and Control
Secondary outcomes
Glycaemic management improved · 1 year · p for improved/stable/deteriorated distribution
P < 0.001
Glycaemic management stable · 1 year
Glycaemic management deteriorated · 1 year
| Outcome | Adjusted estimated treatment effect (kg) (95% CI) | P value |
|---|---|---|
| Body weight · 12 monthsIntention-to-treat analyses | −3.6 (−5.2 to −2.1) | P < 0.001 |
Original publication
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